Surgical Anchoring Systems for Endoluminal Access

ABSTRACT

Surgical anchoring systems for use with a surgical instrument for endoluminal access are provided. The surgical instrument includes an outer sleeve defining a working channel therethrough. The outer sleeve is configured to be disposed within a first natural body lumen. A channel arm is configured to extend through the working channel and to move independently relative to each other. The channel arm has an anchor member and is configured to move between expanded and unexpanded states. When in the expanded state, the anchor member is configured to be disposed within a second natural body lumen. A control actuator extends along the channel arm and is operatively coupled to the anchor member, the control actuator being operatively coupled to a drive system that is configured to control motion of the channel arm to selectively manipulate an organ associated with the first and second natural body lumens.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 63/249,980 filed on Sep. 29, 2021, and entitled “CooperativeAccess,” the disclosure of which is incorporated herein by reference inits entirety.

FIELD

The present invention relates generally to surgical systems and methodsof using the same for anchoring, cooperative endoscopic and laparoscopicaccess and tissue manipulation, etc.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowmedical practitioners to view a surgical site and/or one or moreportions thereof on one or more displays, (e.g., a monitor, a computertablet screen, etc.). The display(s) can be local and/or remote to asurgical theater. The imaging system can include a scope with a camerathat views the surgical site and transmits the view to the one or moredisplays viewable by medical practitioner(s).

Imaging systems can be limited by the information that they are able torecognize and/or convey to the medical practitioner(s). For example,certain concealed structures, physical contours, and/or dimensionswithin a three-dimensional space may be unrecognizable intraoperativelyby certain imaging systems. For another example, certain imaging systemsmay be incapable of communicating and/or conveying certain informationto the medical practitioner(s) intraoperatively.

Accordingly, there remains a need for improved surgical imaging.

SUMMARY

Surgical anchoring systems are provided. In one exemplary embodiment, asurgical anchoring system anchoring system includes a surgicalinstrument having an outer sleeve defining a working channeltherethrough and configured to be at least partially disposed within afirst natural body lumen, and at least one channel arm configured toextend through the working channel and configured to move independentlyrelative to each other. The at least one channel arm has at least oneanchor member coupled to the at least one channel arm and at least onecontrol actuator that extends along the at least one channel arm and isoperatively coupled to the at least one anchor member. The at least oneanchor member is configured to move between expanded and unexpandedstates, and when in the expanded state, the at least one anchor memberis configured to be at least partially disposed within a second naturalbody lumen, the second natural body lumen being in communication withthe first natural body lumen. The at least one control actuator isoperatively coupled to a drive system that is configured to controlmotion of the at least one channel arm to selectively manipulate anorgan associated with the first and second natural body lumens.

The surgical instrument can have a variety of configurations. In someembodiments, the surgical instrument can include an anchoring balloonarranged proximal to a distal end of the outer sleeve. In certainembodiments, the anchoring balloon can be configured to expand and atleast partially contact an internal surface of the first natural bodylumen.

The anchor member can have a variety of configurations. In someembodiments, the at least one anchor member can be configured to expandand at least partially contact the internal surface of the secondnatural body lumen. In certain embodiments, the at least one anchormember can be configured to move axially along a length of the channelarm. In such embodiments, the at least one anchor member can beconfigured to be selectively locked at an axial position along thelength of the at least one channel arm by a releasable lockingmechanism.

The at least one channel arm can have a variety of configurations. Insome embodiments, the at least one channel arm can be configured toapply a force to the second natural body lumen through at least oneanchor member so as to manipulate the second natural body lumen relativeto the first natural body lumen. In certain embodiments, the at leastone channel arm can include an optical sensor arranged at a distal endof the at least one channel arm.

In some embodiments, the surgical anchoring system can include acontroller that can be configured to coordinate a motion of the at leastone channel arm within the second natural body lumen and a motion of atleast one instrument outside of the second natural body lumen to preventtearing of the second natural body lumen.

In another exemplary embodiment, a surgical anchoring system includes atubular member and an anchoring assembly coupled to a distal portion ofthe tubular member and extending distally therefrom. The tubular memberis configured for endoluminal access and has a central lumen thereinconfigured to allow an endoscope to pass therethrough. The anchoringassembly includes a first anchor member coupled to the tubular memberand a second anchor member that is moveable relative to the first anchormember and positioned distal to the first anchor member. The firstanchor member is configured to engage a first anatomical location andsecure the first anatomical location relative to the tubular member, andthe second anchor member is configured to engage a second anatomicallocation that is moveable relative to the first anatomical location, inwhich movement of the second anchor member relative to the first anchormember is effective to selectively reposition the second anatomicallocation relative to the first anatomical location.

The first and second anchor members can have a variety ofconfigurations. In some embodiments, the first anchor member can includea first plurality of working channels extending therethrough and a firstplurality of expandable anchoring elements. In such embodiments, thesecond anchor member can include a second plurality of working channelsextending therethrough and a second plurality of expandable anchoringelements. In such embodiments, the tubular member can include a thirdplurality of working channels extending therethrough.

In some embodiments, the surgical anchoring system can include aplurality of first actuators that pass through first working channels ofthe first plurality of working channels of the first anchor member andfirst working channels of the third plurality of working channels of thetubular member. In such embodiments, the plurality of first actuatorscan be configured to rotate to expand the first plurality of expandableanchoring elements.

In other embodiments, the surgical anchoring system can include aplurality of second actuators that pass through second working channelsof the first plurality of working channels of the first anchor member,first working channels of the second plurality of working channels ofthe second anchor member, and second working channels of the thirdplurality of working channels of the tubular member. In suchembodiments, the plurality of second actuators can be configured torotate to expand the second plurality of expandable anchoring elements.

In yet other embodiments, the surgical anchoring system can include aplurality of third actuators that pass through third working channels ofthe first plurality of working channels of the first anchor member andthird working channels of the third plurality of working channels of thetubular member, and can terminate at a proximal surface of the secondanchor member. In certain embodiments, the plurality of third actuatorscan be configured to rotate to axially displace the second anchorrelative to the first anchor. In some embodiments, the plurality ofthird actuators can be configured to be extended, retracted, or bent toselectively reposition the second anatomical location relative to thefirst anatomical location.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is described by way of reference to theaccompanying figures which are as follows:

FIG. 1 is a schematic view of one embodiment of a surgical visualizationsystem;

FIG. 2 is a schematic view of triangularization between a surgicaldevice, an imaging device, and a critical structure of FIG. 1 ;

FIG. 3 is a schematic view of another embodiment of a surgicalvisualization system;

FIG. 4 is a schematic view of one embodiment of a control system for asurgical visualization system;

FIG. 5 is a schematic view of one embodiment of a control circuit of acontrol system for a surgical visualization system;

FIG. 6 is a schematic view of one embodiment of a combinational logiccircuit of a surgical visualization system;

FIG. 7 is a schematic view of one embodiment of a sequential logiccircuit of a surgical visualization system;

FIG. 8 is a schematic view of yet another embodiment of a surgicalvisualization system;

FIG. 9 is a schematic view of another embodiment of a control system fora surgical visualization system;

FIG. 10 is a graph showing wavelength versus absorption coefficient forvarious biological materials;

FIG. 11 is a schematic view of one embodiment of a spectral emittervisualizing a surgical site;

FIG. 12 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a ureter from obscurants;

FIG. 13 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate an artery from obscurants;

FIG. 14 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a nerve from obscurants;

FIG. 15 is a schematic view of one embodiment of a near infrared (NIR)time-of-flight measurement system being utilized intraoperatively;

FIG. 16 shows a time-of-flight timing diagram for the system of FIG. 15;

FIG. 17 is a schematic view of another embodiment of a near infrared(NIR) time-of-flight measurement system being utilized intraoperatively;

FIG. 18 is a schematic view of one embodiment of a computer-implementedinteractive surgical system;

FIG. 19 is a schematic view of one embodiment a surgical system beingused to perform a surgical procedure in an operating room;

FIG. 20 is a schematic view of one embodiment of a surgical systemincluding a smart surgical instrument and a surgical hub;

FIG. 21 is a flowchart showing a method of controlling the smartsurgical instrument of FIG. 20 ;

FIG. 22 is a schematic view of one embodiment of a surgical anchoringsystem having an outer sleeve and channel arms that extend through theouter sleeve in which the channel arms include respective anchormembers, showing the surgical anchoring system inserted through a throatand into a lung with a portion the outer sleeve passing through thethroat and into the lung and the channel arms extending through theouter sleeve and into respective portions of the lung with therespective anchor members in an unexpanded state;

FIG. 23A is a magnified view of a portion of one of the channel arms ofthe surgical anchoring system of FIG. 22 with the lung removed and aportion of the respective anchor members;

FIG. 23B is the channel arm of FIG. 23A, showing the anchor members inan expanded state;

FIG. 24 is a magnified view of a distal end of a channel arm of thesurgical anchoring system of FIG. 22 with the lung removed;

FIG. 25 is a magnified view of a portion of the surgical anchoringsystem of FIG. 22 with the lung removed;

FIG. 26 is a schematic view of the surgical anchoring system of FIG. 22, showing the anchor members in an expanded state while manipulating thelung from an intraluminal space and from an extraluminal space usinglaparoscopically inserted instruments;

FIG. 27 is a schematic view of another embodiment of a surgicalanchoring system, showing the surgical anchoring system inserted throughthe throat and into a lung;

FIG. 28 is a schematic view of a colon;

FIG. 29 is a schematic view of a conventional surgical system insertedinto an organ;

FIG. 30 is a schematic view of another embodiment of a surgicalanchoring system having first and second anchor members, showing thefirst and second anchor members in an unexpanded state;

FIG. 31 is a schematic view of the surgical anchoring system of FIG. 30, showing the first and second anchor members in an expanded state;

FIG. 32 is a cross-sectional view of the surgical anchoring system ofFIG. 31 , showing the surgical anchoring system inserted into an organ;and

FIG. 33 is a schematic view of another embodiment of a surgicalanchoring system having a circular stapler and anvil, each having atracking means, showing the surgical anchoring system inserted throughrectum and into a colon with a portion the circular stapler passingthrough the rectum and into the colon and the anvil passing through amobilized portion of the colon.

FIG. 34 is a schematic view of a stomach;

FIG. 35 is a schematic view of a conventional surgical system having alaparoscope and an endoscope, showing the laparoscope positioned outsideof a stomach and an endoscope positioned within the stomach;

FIG. 36 is a schematic view of the stomach of FIG. 35 , showing aconventional wedge resection to remove a tumor from the stomach usingthe surgical system of FIG. 35 ;

FIG. 37 is a schematic view of an embodiment of a surgical system havinga laparoscope, laparoscopic instruments, and an endoscope, showing thelaparoscope and laparoscopic instruments positioned outside of a stomachand the endoscope positioned within the stomach;

FIG. 38 is a schematic view of the surgical system of FIG. 37 , showingthe relative distances between the laparoscope, the laparoscopicinstruments, the endoscope, and a tumor within the stomach;

FIG. 39 is a schematic view of a merged image of the surgical system ofFIG. 37 from the perspective of the endoscope;

FIG. 40 is a schematic view of a merged image of the surgical system ofFIG. 38 from the perspective of the laparoscope;

FIG. 41 is a schematic view of the surgical system of FIG. 40 , showinga partial removal of a tumor arranged within the stomach by anendoscopically arranged instrument;

FIG. 41 a is a schematic view of a merged image of the surgical systemof FIG. 41 from the perspective of the endoscope;

FIG. 42 is a schematic view of the surgical system of FIG. 41 , showingthe partial removal of a tumor from an inner tissue wall of a stomach;

FIG. 42 a is a schematic view of a merged image of the surgical systemof FIG. 42 from the perspective of the endoscope;

FIG. 43 is a schematic view of the surgical system of FIG. 42 , showingmobilization of an upper portion of the stomach by the laparoscopicallyarranged instrument;

FIG. 43 a is a schematic view of a merged image of the surgical systemof FIG. 43 from the perspective of the endoscope;

FIG. 44 a is a detailed view of another embodiment of a surgical system,showing the removal of a damaged portion of tissue from a colon;

FIG. 44 b is a detailed view of the surgical system of FIG. 44 a ,showing an incision in the seromuscular layer;

FIG. 44 c is a detailed view of the surgical system of FIG. 44 b ,showing an endoscopic balloon inflation;

FIG. 44 d is a detailed view of the surgical system of FIG. 44 c ,showing a lesion removal;

FIG. 44 e is a detailed view of the surgical system of FIG. 44 d ,showing a sealing of the colon;

FIG. 45 is a schematic view of another embodiment of a surgical system,showing a removal of a tumor from a stomach by a laparoscopicallyarranged instrument;

FIG. 46 is a schematic view of a merged image of the surgical system ofFIG. 45 from the perspective of the laparoscope;

FIG. 47 is a schematic view of the surgical system of FIG. 45 , showinga tissue strain measurement using markers arranged on the inner tissuesurface of the stomach; and

FIG. 48 is a schematic view of another embodiment of a surgical system,showing the removal of lymph nodes from the outer tissue wall of astomach.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices, systems, and methods disclosedherein. One or more examples of these embodiments are illustrated in theaccompanying drawings. A person skilled in the art will understand thatthe devices, systems, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. A person skilled inthe art will appreciate that a dimension may not be a precise value butnevertheless be considered to be at about that value due to any numberof factors such as manufacturing tolerances and sensitivity ofmeasurement equipment. Sizes and shapes of the systems and devices, andthe components thereof, can depend at least on the size and shape ofcomponents with which the systems and devices will be used.

Surgical Visualization

In general, a surgical visualization system is configured to leverage“digital surgery” to obtain additional information about a patient'sanatomy and/or a surgical procedure. The surgical visualization systemis further configured to convey data to one or more medicalpractitioners in a helpful manner. Various aspects of the presentdisclosure provide improved visualization of the patient's anatomyand/or the surgical procedure, and/or use visualization to provideimproved control of a surgical tool (also referred to herein as a“surgical device” or a “surgical instrument”).

“Digital surgery” can embrace robotic systems, advanced imaging,advanced instrumentation, artificial intelligence, machine learning,data analytics for performance tracking and benchmarking, connectivityboth inside and outside of the operating room (OR), and more. Althoughvarious surgical visualization systems described herein can be used incombination with a robotic surgical system, surgical visualizationsystems are not limited to use with a robotic surgical system. Incertain instances, surgical visualization using a surgical visualizationsystem can occur without robotics and/or with limited and/or optionalrobotic assistance. Similarly, digital surgery can occur withoutrobotics and/or with limited and/or optional robotic assistance.

In certain instances, a surgical system that incorporates a surgicalvisualization system may enable smart dissection in order to identifyand avoid critical structures. Critical structures include anatomicalstructures such as a ureter, an artery such as a superior mesentericartery, a vein such as a portal vein, a nerve such as a phrenic nerve,and/or a tumor, among other anatomical structures. In other instances, acritical structure can be a foreign structure in the anatomical field,such as a surgical device, a surgical fastener, a clip, a tack, abougie, a band, a plate, and other foreign structures. Criticalstructures can be determined on a patient-by-patient and/or aprocedure-by-procedure basis. Smart dissection technology may provide,for example, improved intraoperative guidance for dissection and/or mayenable smarter decisions with critical anatomy detection and avoidancetechnology.

A surgical system incorporating a surgical visualization system mayenable smart anastomosis technologies that provide more consistentanastomoses at optimal location(s) with improved workflow. Cancerlocalization technologies may be improved with a surgical visualizationplatform. For example, cancer localization technologies can identify andtrack a cancer location, orientation, and its margins. In certaininstances, the cancer localization technologies may compensate formovement of a surgical instrument, a patient, and/or the patient'sanatomy during a surgical procedure in order to provide guidance back tothe point of interest for medical practitioner(s).

A surgical visualization system may provide improved tissuecharacterization and/or lymph node diagnostics and mapping. For example,tissue characterization technologies may characterize tissue type andhealth without the need for physical haptics, especially when dissectingand/or placing stapling devices within the tissue. Certain tissuecharacterization technologies may be utilized without ionizing radiationand/or contrast agents. With respect to lymph node diagnostics andmapping, a surgical visualization platform may, for example,preoperatively locate, map, and ideally diagnose the lymph system and/orlymph nodes involved in cancerous diagnosis and staging.

During a surgical procedure, information available to a medicalpractitioner via the “naked eye” and/or an imaging system may provide anincomplete view of the surgical site. For example, certain structures,such as structures embedded or buried within an organ, can be at leastpartially concealed or hidden from view. Additionally, certaindimensions and/or relative distances can be difficult to ascertain withexisting sensor systems and/or difficult for the “naked eye” toperceive. Moreover, certain structures can move pre-operatively (e.g.,before a surgical procedure but after a preoperative scan) and/orintraoperatively. In such instances, the medical practitioner can beunable to accurately determine the location of a critical structureintraoperatively.

When the position of a critical structure is uncertain and/or when theproximity between the critical structure and a surgical tool is unknown,a medical practitioner's decision-making process can be inhibited. Forexample, a medical practitioner may avoid certain areas in order toavoid inadvertent dissection of a critical structure; however, theavoided area may be unnecessarily large and/or at least partiallymisplaced. Due to uncertainty and/or overly/excessive exercises incaution, the medical practitioner may not access certain desiredregions. For example, excess caution may cause a medical practitioner toleave a portion of a tumor and/or other undesirable tissue in an effortto avoid a critical structure even if the critical structure is not inthe particular area and/or would not be negatively impacted by themedical practitioner working in that particular area. In certaininstances, surgical results can be improved with increased knowledgeand/or certainty, which can allow a surgeon to be more accurate and, incertain instances, less conservative/more aggressive with respect toparticular anatomical areas.

A surgical visualization system can allow for intraoperativeidentification and avoidance of critical structures. The surgicalvisualization system may thus enable enhanced intraoperative decisionmaking and improved surgical outcomes. The surgical visualization systemcan provide advanced visualization capabilities beyond what a medicalpractitioner sees with the “naked eye” and/or beyond what an imagingsystem can recognize and/or convey to the medical practitioner. Thesurgical visualization system can augment and enhance what a medicalpractitioner is able to know prior to tissue treatment (e.g.,dissection, etc.) and, thus, may improve outcomes in various instances.As a result, the medical practitioner can confidently maintain momentumthroughout the surgical procedure knowing that the surgicalvisualization system is tracking a critical structure, which may beapproached during dissection, for example. The surgical visualizationsystem can provide an indication to the medical practitioner insufficient time for the medical practitioner to pause and/or slow downthe surgical procedure and evaluate the proximity to the criticalstructure to prevent inadvertent damage thereto. The surgicalvisualization system can provide an ideal, optimized, and/orcustomizable amount of information to the medical practitioner to allowthe medical practitioner to move confidently and/or quickly throughtissue while avoiding inadvertent damage to healthy tissue and/orcritical structure(s) and, thus, to minimize the risk of harm resultingfrom the surgical procedure.

Surgical visualization systems are described in detail below. Ingeneral, a surgical visualization system can include a first lightemitter configured to emit a plurality of spectral waves, a second lightemitter configured to emit a light pattern, and a receiver, or sensor,configured to detect visible light, molecular responses to the spectralwaves (spectral imaging), and/or the light pattern. The surgicalvisualization system can also include an imaging system and a controlcircuit in signal communication with the receiver and the imagingsystem. Based on output from the receiver, the control circuit candetermine a geometric surface map, e.g., three-dimensional surfacetopography, of the visible surfaces at the surgical site and a distancewith respect to the surgical site, such as a distance to an at leastpartially concealed structure. The imaging system can convey thegeometric surface map and the distance to a medical practitioner. Insuch instances, an augmented view of the surgical site provided to themedical practitioner can provide a representation of the concealedstructure within the relevant context of the surgical site. For example,the imaging system can virtually augment the concealed structure on thegeometric surface map of the concealing and/or obstructing tissuesimilar to a line drawn on the ground to indicate a utility line belowthe surface. Additionally or alternatively, the imaging system canconvey the proximity of a surgical tool to the visible and obstructingtissue and/or to the at least partially concealed structure and/or adepth of the concealed structure below the visible surface of theobstructing tissue. For example, the visualization system can determinea distance with respect to the augmented line on the surface of thevisible tissue and convey the distance to the imaging system.

Throughout the present disclosure, any reference to “light,” unlessspecifically in reference to visible light, can include electromagneticradiation (EMR) or photons in the visible and/or non-visible portions ofthe EMR wavelength spectrum. The visible spectrum, sometimes referred toas the optical spectrum or luminous spectrum, is that portion of theelectromagnetic spectrum that is visible to (e.g., can be detected by)the human eye and may be referred to as “visible light” or simply“light.” A typical human eye will respond to wavelengths in air that arefrom about 380 nm to about 750 nm. The invisible spectrum (e.g., thenon-luminous spectrum) is that portion of the electromagnetic spectrumthat lies below and above the visible spectrum. The invisible spectrumis not detectable by the human eye. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisibleinfrared (IR), microwave, and radio electromagnetic radiation.Wavelengths less than about 380 nm are shorter than the violet spectrum,and they become invisible ultraviolet, x-ray, and gamma rayelectromagnetic radiation.

FIG. 1 illustrates one embodiment of a surgical visualization system100. The surgical visualization system 100 is configured to create avisual representation of a critical structure 101 within an anatomicalfield. The critical structure 101 can include a single criticalstructure or a plurality of critical structures. As discussed herein,the critical structure 101 can be any of a variety of structures, suchas an anatomical structure, e.g., a ureter, an artery such as a superiormesenteric artery, a vein such as a portal vein, a nerve such as aphrenic nerve, a vessel, a tumor, or other anatomical structure, or aforeign structure, e.g., a surgical device, a surgical fastener, asurgical clip, a surgical tack, a bougie, a surgical band, a surgicalplate, or other foreign structure. As discussed herein, the criticalstructure 101 can be identified on a patient-by-patient and/or aprocedure-by-procedure basis. Embodiments of critical structures and ofidentifying critical structures using a visualization system are furtherdescribed in U.S. Pat. No. 10,792,034 entitled “Visualization OfSurgical Devices” issued Oct. 6, 2020, which is hereby incorporated byreference in its entirety.

In some instances, the critical structure 101 can be embedded in tissue103. The tissue 103 can be any of a variety of tissues, such as fat,connective tissue, adhesions, and/or organs. Stated differently, thecritical structure 101 may be positioned below a surface 105 of thetissue 103. In such instances, the tissue 103 conceals the criticalstructure 101 from the medical practitioner's “naked eye” view. Thetissue 103 also obscures the critical structure 101 from the view of animaging device 120 of the surgical visualization system 100. Instead ofbeing fully obscured, the critical structure 101 can be partiallyobscured from the view of the medical practitioner and/or the imagingdevice 120.

The surgical visualization system 100 can be used for clinical analysisand/or medical intervention. In certain instances, the surgicalvisualization system 100 can be used intraoperatively to providereal-time information to the medical practitioner during a surgicalprocedure, such as real-time information regarding proximity data,dimensions, and/or distances. A person skilled in the art willappreciate that information may not be precisely real time butnevertheless be considered to be real time for any of a variety ofreasons, such as time delay induced by data transmission, time delayinduced by data processing, and/or sensitivity of measurement equipment.The surgical visualization system 100 is configured for intraoperativeidentification of critical structure(s) and/or to facilitate theavoidance of the critical structure(s) 101 by a surgical device. Forexample, by identifying the critical structure 101, a medicalpractitioner can avoid maneuvering a surgical device around the criticalstructure 101 and/or a region in a predefined proximity of the criticalstructure 101 during a surgical procedure. For another example, byidentifying the critical structure 101, a medical practitioner can avoiddissection of and/or near the critical structure 101, thereby helping toprevent damage to the critical structure 101 and/or helping to prevent asurgical device being used by the medical practitioner from beingdamaged by the critical structure 101.

The surgical visualization system 100 is configured to incorporatetissue identification and geometric surface mapping in combination withthe surgical visualization system's distance sensor system 104. Incombination, these features of the surgical visualization system 100 candetermine a position of a critical structure 101 within the anatomicalfield and/or the proximity of a surgical device 102 to the surface 105of visible tissue 103 and/or to the critical structure 101. Moreover,the surgical visualization system 100 includes an imaging system thatincludes the imaging device 120 configured to provide real-time views ofthe surgical site. The imaging device 120 can include, for example, aspectral camera (e.g., a hyperspectral camera, multispectral camera, orselective spectral camera), which is configured to detect reflectedspectral waveforms and generate a spectral cube of images based on themolecular response to the different wavelengths. Views from the imagingdevice 120 can be provided in real time to a medical practitioner, suchas on a display (e.g., a monitor, a computer tablet screen, etc.). Thedisplayed views can be augmented with additional information based onthe tissue identification, landscape mapping, and the distance sensorsystem 104. In such instances, the surgical visualization system 100includes a plurality of subsystems—an imaging subsystem, a surfacemapping subsystem, a tissue identification subsystem, and/or a distancedetermining subsystem. These subsystems can cooperate tointra-operatively provide advanced data synthesis and integratedinformation to the medical practitioner.

The imaging device 120 can be configured to detect visible light,spectral light waves (visible or invisible), and a structured lightpattern (visible or invisible). Examples of the imaging device 120includes scopes, e.g., an endoscope, an arthroscope, an angioscope, abronchoscope, a choledochoscope, a colonoscope, a cytoscope, aduodenoscope, an enteroscope, an esophagogastro-duodenoscope(gastroscope), a laryngoscope, a nasopharyngo-neproscope, asigmoidoscope, a thoracoscope, an ureteroscope, or an exoscope. Scopescan be particularly useful in minimally invasive surgical procedures. Inopen surgery applications, the imaging device 120 may not include ascope.

The tissue identification subsystem can be achieved with a spectralimaging system. The spectral imaging system can rely on imaging such ashyperspectral imaging, multispectral imaging, or selective spectralimaging. Embodiments of hyperspectral imaging of tissue are furtherdescribed in U.S. Pat. No. 9,274,047 entitled “System And Method ForGross Anatomic Pathology Using Hyperspectral Imaging” issued Mar. 1,2016, which is hereby incorporated by reference in its entirety.

The surface mapping subsystem can be achieved with a light patternsystem. Various surface mapping techniques using a light pattern (orstructured light) for surface mapping can be utilized in the surgicalvisualization systems described herein. Structured light is the processof projecting a known pattern (often a grid or horizontal bars) on to asurface. In certain instances, invisible (or imperceptible) structuredlight can be utilized, in which the structured light is used withoutinterfering with other computer vision tasks for which the projectedpattern may be confusing. For example, infrared light or extremely fastframe rates of visible light that alternate between two exact oppositepatterns can be utilized to prevent interference. Embodiments of surfacemapping and a surgical system including a light source and a projectorfor projecting a light pattern are further described in U.S. Pat. Pub.No. 2017/0055819 entitled “Set Comprising A Surgical Instrument”published Mar. 2, 2017, U.S. Pat. Pub. No. 2017/0251900 entitled“Depiction System” published Sep. 7, 2017, and U.S. patent applicationSer. No. 16/729,751 entitled “Surgical Systems For Generating ThreeDimensional Constructs Of Anatomical Organs And Coupling IdentifiedAnatomical Structures Thereto” filed Dec. 30, 2019, which are herebyincorporated by reference in their entireties.

The distance determining system can be incorporated into the surfacemapping system. For example, structured light can be utilized togenerate a three-dimensional (3D) virtual model of the visible surface105 and determine various distances with respect to the visible surface105. Additionally or alternatively, the distance determining system canrely on time-of-flight measurements to determine one or more distancesto the identified tissue (or other structures) at the surgical site.

The surgical visualization system 100 also includes a surgical device102. The surgical device 102 can be any suitable surgical device.Examples of the surgical device 102 includes a surgical dissector, asurgical stapler, a surgical grasper, a clip applier, a smoke evacuator,a surgical energy device (e.g., mono-polar probes, bi-polar probes,ablation probes, an ultrasound device, an ultrasonic end effector,etc.), etc. In some embodiments, the surgical device 102 includes an endeffector having opposing jaws that extend from a distal end of a shaftof the surgical device 102 and that are configured to engage tissuetherebetween.

The surgical visualization system 100 can be configured to identify thecritical structure 101 and a proximity of the surgical device 102 to thecritical structure 101. The imaging device 120 of the surgicalvisualization system 100 is configured to detect light at variouswavelengths, such as visible light, spectral light waves (visible orinvisible), and a structured light pattern (visible or invisible). Theimaging device 120 can include a plurality of lenses, sensors, and/orreceivers for detecting the different signals. For example, the imagingdevice 120 can be a hyperspectral, multispectral, or selective spectralcamera, as described herein. The imaging device 120 can include awaveform sensor 122 (such as a spectral image sensor, detector, and/orthree-dimensional camera lens). For example, the imaging device 120 caninclude a right-side lens and a left-side lens used together to recordtwo two-dimensional images at the same time and, thus, generate athree-dimensional (3D) image of the surgical site, render athree-dimensional image of the surgical site, and/or determine one ormore distances at the surgical site. Additionally or alternatively, theimaging device 120 can be configured to receive images indicative of thetopography of the visible tissue and the identification and position ofhidden critical structures, as further described herein. For example, afield of view of the imaging device 120 can overlap with a pattern oflight (structured light) on the surface 105 of the tissue 103, as shownin FIG. 1 .

As in this illustrated embodiment, the surgical visualization system 100can be incorporated into a robotic surgical system 110. The roboticsurgical system 110 can have a variety of configurations, as discussedherein. In this illustrated embodiment, the robotic surgical system 110includes a first robotic arm 112 and a second robotic arm 114. Therobotic arms 112, 114 each include rigid structural members 116 andjoints 118, which can include servomotor controls. The first robotic arm112 is configured to maneuver the surgical device 102, and the secondrobotic arm 114 is configured to maneuver the imaging device 120. Arobotic control unit of the robotic surgical system 110 is configured toissue control motions to the first and second robotic arms 112, 114,which can affect the surgical device 102 and the imaging device 120,respectively.

In some embodiments, one or more of the robotic arms 112, 114 can beseparate from the main robotic system 110 used in the surgicalprocedure. For example, at least one of the robotic arms 112, 114 can bepositioned and registered to a particular coordinate system without aservomotor control. For example, a closed-loop control system and/or aplurality of sensors for the robotic arms 112, 114 can control and/orregister the position of the robotic arm(s) 112, 114 relative to theparticular coordinate system. Similarly, the position of the surgicaldevice 102 and the imaging device 120 can be registered relative to aparticular coordinate system.

Examples of robotic surgical systems include the Ottava™robotic-assisted surgery system (Johnson & Johnson of New Brunswick,N.J.), da Vinci® surgical systems (Intuitive Surgical, Inc. ofSunnyvale, Calif.), the Hugo™ robotic-assisted surgery system (MedtronicPLC of Minneapolis, Minn.), the Versius® surgical robotic system (CMRSurgical Ltd of Cambridge, UK), and the Monarch® platform (Auris Health,Inc. of Redwood City, Calif.). Embodiments of various robotic surgicalsystems and using robotic surgical systems are further described in U.S.Pat. Pub. No. 2018/0177556 entitled “Flexible Instrument Insertion UsingAn Adaptive Force Threshold” filed Dec. 28, 2016, U.S. Pat. Pub. No.2020/0000530 entitled “Systems And Techniques For Providing MultiplePerspectives During Medical Procedures” filed Apr. 16, 2019, U.S. Pat.Pub. No. 2020/0170720 entitled “Image-Based Branch Detection And MappingFor Navigation” filed Feb. 7, 2020, U.S. Pat. Pub. No. 2020/0188043entitled “Surgical Robotics System” filed Dec. 9, 2019, U.S. Pat. Pub.No. 2020/0085516 entitled “Systems And Methods For Concomitant MedicalProcedures” filed Sep. 3, 2019, U.S. Pat. No. 8,831,782 entitled“Patient-Side Surgeon Interface For A Teleoperated Surgical Instrument”filed Jul. 15, 2013, and Intl. Pat. Pub. No. WO 2014151621 entitled“Hyperdexterous Surgical System” filed Mar. 13, 2014, which are herebyincorporated by reference in their entireties.

The surgical visualization system 100 also includes an emitter 106. Theemitter 106 is configured to emit a pattern of light, such as stripes,grid lines, and/or dots, to enable the determination of the topographyor landscape of the surface 105. For example, projected light arrays 130can be used for three-dimensional scanning and registration on thesurface 105. The projected light arrays 130 can be emitted from theemitter 106 located on the surgical device 102 and/or one of the roboticarms 112, 114 and/or the imaging device 120. In one aspect, theprojected light array 130 is employed by the surgical visualizationsystem 100 to determine the shape defined by the surface 105 of thetissue 103 and/or motion of the surface 105 intraoperatively. Theimaging device 120 is configured to detect the projected light arrays130 reflected from the surface 105 to determine the topography of thesurface 105 and various distances with respect to the surface 105.

As in this illustrated embodiment, the imaging device 120 can include anoptical waveform emitter 123, such as by being mounted on or otherwiseattached on the imaging device 120. The optical waveform emitter 123 isconfigured to emit electromagnetic radiation 124 (near-infrared (NIR)photons) that can penetrate the surface 105 of the tissue 103 and reachthe critical structure 101. The imaging device 120 and the opticalwaveform emitter 123 can be positionable by the robotic arm 114. Theoptical waveform emitter 123 is mounted on or otherwise on the imagingdevice 122 but in other embodiments can be positioned on a separatesurgical device from the imaging device 120. A corresponding waveformsensor 122 (e.g., an image sensor, spectrometer, or vibrational sensor)of the imaging device 120 is configured to detect the effect of theelectromagnetic radiation received by the waveform sensor 122. Thewavelengths of the electromagnetic radiation 124 emitted by the opticalwaveform emitter 123 are configured to enable the identification of thetype of anatomical and/or physical structure, such as the criticalstructure 101. The identification of the critical structure 101 can beaccomplished through spectral analysis, photo-acoustics, and/orultrasound, for example. In one aspect, the wavelengths of theelectromagnetic radiation 124 can be variable. The waveform sensor 122and optical waveform emitter 123 can be inclusive of a multispectralimaging system and/or a selective spectral imaging system, for example.In other instances, the waveform sensor 122 and optical waveform emitter123 can be inclusive of a photoacoustic imaging system, for example.

The distance sensor system 104 of the surgical visualization system 100is configured to determine one or more distances at the surgical site.The distance sensor system 104 can be a time-of-flight distance sensorsystem that includes an emitter, such as the emitter 106 as in thisillustrated embodiment, and that includes a receiver 108. In otherinstances, the time-of-flight emitter can be separate from thestructured light emitter. The emitter 106 can include a very tiny lasersource, and the receiver 108 can include a matching sensor. The distancesensor system 104 is configured to detect the “time of flight,” or howlong the laser light emitted by the emitter 106 has taken to bounce backto the sensor portion of the receiver 108. Use of a very narrow lightsource in the emitter 106 enables the distance sensor system 104 todetermining the distance to the surface 105 of the tissue 103 directlyin front of the distance sensor system 104.

The receiver 108 of the distance sensor system 104 is positioned on thesurgical device 102 in this illustrated embodiment, but in otherembodiments the receiver 108 can be mounted on a separate surgicaldevice instead of the surgical device 102. For example, the receiver 108can be mounted on a cannula or trocar through which the surgical device102 extends to reach the surgical site. In still other embodiments, thereceiver 108 for the distance sensor system 104 can be mounted on aseparate robotically-controlled arm of the robotic system 110 (e.g., onthe second robotic arm 114) than the first robotic arm 112 to which thesurgical device 102 is coupled, can be mounted on a movable arm that isoperated by another robot, or be mounted to an operating room (OR) tableor fixture. In some embodiments, the imaging device 120 includes thereceiver 108 to allow for determining the distance from the emitter 106to the surface 105 of the tissue 103 using a line between the emitter106 on the surgical device 102 and the imaging device 120. For example,the distance d_(e) can be triangulated based on known positions of theemitter 106 (on the surgical device 102) and the receiver 108 (on theimaging device 120) of the distance sensor system 104. Thethree-dimensional position of the receiver 108 can be known and/orregistered to the robot coordinate plane intraoperatively.

As in this illustrated embodiment, the position of the emitter 106 ofthe distance sensor system 104 can be controlled by the first roboticarm 112, and the position of the receiver 108 of the distance sensorsystem 104 can be controlled by the second robotic arm 114. In otherembodiments, the surgical visualization system 100 can be utilized apartfrom a robotic system. In such instances, the distance sensor system 104can be independent of the robotic system.

In FIG. 1 , d_(e) is emitter-to-tissue distance from the emitter 106 tothe surface 105 of the tissue 103, and d_(t) is device-to-tissuedistance from a distal end of the surgical device 102 to the surface 105of the tissue 103. The distance sensor system 104 is configured todetermine the emitter-to-tissue distance d_(e). The device-to-tissuedistance d_(t) is obtainable from the known position of the emitter 106on the surgical device 102, e.g., on a shaft thereof proximal to thesurgical device's distal end, relative to the distal end of the surgicaldevice 102. In other words, when the distance between the emitter 106and the distal end of the surgical device 102 is known, thedevice-to-tissue distance d_(t) can be determined from theemitter-to-tissue distance d_(e). In some embodiments, the shaft of thesurgical device 102 can include one or more articulation joints and canbe articulatable with respect to the emitter 106 and jaws at the distalend of the surgical device 102. The articulation configuration caninclude a multi-joint vertebrae-like structure, for example. In someembodiments, a three-dimensional camera can be utilized to triangulateone or more distances to the surface 105.

In FIG. 1 , d_(w) is camera-to-critical structure distance from theoptical waveform emitter 123 located on the imaging device 120 to thesurface of the critical structure 101, and d_(A) is a depth of thecritical structure 101 below the surface 105 of the tissue 103 (e.g.,the distance between the portion of the surface 105 closest to thesurgical device 102 and the critical structure 101). The time-of-flightof the optical waveforms emitted from the optical waveform emitter 123located on the imaging device 120 are configured to determine thecamera-to-critical structure distance d_(w).

As shown in FIG. 2 , the depth d_(A) of the critical structure 101relative to the surface 105 of the tissue 103 can be determined bytriangulating from the distance d_(w) and known positions of the emitter106 on the surgical device 102 and the optical waveform emitter 123 onthe imaging device 120 (and, thus, the known distance d_(x)therebetween) to determine the distance d_(y), which is the sum of thedistances d_(e) and d_(A). Additionally or alternatively, time-of-flightfrom the optical waveform emitter 123 can be configured to determine thedistance from the optical waveform emitter 123 to the surface 105 of thetissue 103. For example, a first waveform (or range of waveforms) can beutilized to determine the camera-to-critical structure distance d_(w)and a second waveform (or range of waveforms) can be utilized todetermine the distance to the surface 105 of the tissue 103. In suchinstances, the different waveforms can be utilized to determine thedepth of the critical structure 101 below the surface 105 of the tissue103.

Additionally or alternatively, the distance d_(A) can be determined froman ultrasound, a registered magnetic resonance imaging (MRI), orcomputerized tomography (CT) scan. In still other instances, thedistance d_(A) can be determined with spectral imaging because thedetection signal received by the imaging device 120 can vary based onthe type of material, e.g., type of the tissue 103. For example, fat candecrease the detection signal in a first way, or a first amount, andcollagen can decrease the detection signal in a different, second way,or a second amount.

In another embodiment of a surgical visualization system 160 illustratedin FIG. 3 , a surgical device 162, and not the imaging device 120,includes the optical waveform emitter 123 and the waveform sensor 122that is configured to detect the reflected waveforms. The opticalwaveform emitter 123 is configured to emit waveforms for determining thedistances d_(t) and d_(w) from a common device, such as the surgicaldevice 162, as described herein. In such instances, the distance d_(A)from the surface 105 of the tissue 103 to the surface of the criticalstructure 101 can be determined as follows:

d _(A) =d _(w) −d _(t)

The surgical visualization system 100 includes a control systemconfigured to control various aspects of the surgical visualizationsystem 100. FIG. 4 illustrates one embodiment of a control system 133that can be utilized as the control system of the surgical visualizationsystem 100 (or other surgical visualization system described herein).The control system 133 includes a control circuit 132 configured to bein signal communication with a memory 134. The memory 134 is configuredto store instructions executable by the control circuit 132, such asinstructions to determine and/or recognize critical structures (e.g.,the critical structure 101 of FIG. 1 ), instructions to determine and/orcompute one or more distances and/or three-dimensional digitalrepresentations, and instructions to communicate information to amedical practitioner. As in this illustrated embodiment, the memory 134can store surface mapping logic 136, imaging logic 138, tissueidentification logic 140, and distance determining logic 141, althoughthe memory 134 can store any combinations of the logics 136, 138, 140,141 and/or can combine various logics together. The control system 133also includes an imaging system 142 including a camera 144 (e.g., theimaging system including the imaging device 120 of FIG. 1 ), a display146 (e.g., a monitor, a computer tablet screen, etc.), and controls 148of the camera 144 and the display 146. The camera 144 includes an imagesensor 135 (e.g., the waveform sensor 122) configured to receive signalsfrom various light sources emitting light at various visible andinvisible spectra (e.g., visible light, spectral imagers,three-dimensional lens, etc.). The display 146 is configured to depictreal, virtual, and/or virtually-augmented images and/or information to amedical practitioner.

In an exemplary embodiment, the image sensor 135 is a solid-stateelectronic device containing up to millions of discrete photodetectorsites called pixels. The image sensor 135 technology falls into one oftwo categories: Charge-Coupled Device (CCD) and Complementary MetalOxide Semiconductor (CMOS) imagers and more recently, short-waveinfrared (SWIR) is an emerging technology in imaging. Another type ofthe image sensor 135 employs a hybrid CCD/CMOS architecture (sold underthe name “sCMOS”) and consists of CMOS readout integrated circuits(ROICs) that are bump bonded to a CCD imaging substrate. CCD and CMOSimage sensors 135 are sensitive to wavelengths in a range of about 350nm to about 1050 nm, such as in a range of about 400 nm to about 1000nm. A person skilled in the art will appreciate that a value may not beprecisely at a value but nevertheless considered to be about that valuefor any of a variety of reasons, such as sensitivity of measurementequipment and manufacturing tolerances. CMOS sensors are, in general,more sensitive to IR wavelengths than CCD sensors. Solid state imagesensors 135 are based on the photoelectric effect and, as a result,cannot distinguish between colors. Accordingly, there are two types ofcolor CCD cameras: single chip and three-chip. Single chip color CCDcameras offer a common, low-cost imaging solution and use a mosaic(e.g., Bayer) optical filter to separate incoming light into a series ofcolors and employ an interpolation algorithm to resolve full colorimages. Each color is, then, directed to a different set of pixels.Three-chip color CCD cameras provide higher resolution by employing aprism to direct each section of the incident spectrum to a differentchip. More accurate color reproduction is possible, as each point inspace of the object has separate RGB intensity values, rather than usingan algorithm to determine the color. Three-chip cameras offer extremelyhigh resolutions.

The control system 133 also includes an emitter (e.g., the emitter 106)including a spectral light source 150 and a structured light source 152each operably coupled to the control circuit 133. A single source can bepulsed to emit wavelengths of light in the spectral light source 150range and wavelengths of light in the structured light source 152 range.Alternatively, a single light source can be pulsed to provide light inthe invisible spectrum (e.g., infrared spectral light) and wavelengthsof light on the visible spectrum. The spectral light source 150 can be,for example, a hyperspectral light source, a multispectral light source,and/or a selective spectral light source. The tissue identificationlogic 140 is configured to identify critical structure(s) (e.g., thecritical structure 101 of FIG. 1 ) via data from the spectral lightsource 150 received by the image sensor 135 of the camera 144. Thesurface mapping logic 136 is configured to determine the surfacecontours of the visible tissue (e.g., the tissue 103) based on reflectedstructured light. With time-of-flight measurements, the distancedetermining logic 141 is configured to determine one or more distance(s)to the visible tissue and/or the critical structure. Output from each ofthe surface mapping logic 136, the tissue identification logic 140, andthe distance determining logic 141 is configured to be provided to theimaging logic 138, and combined, blended, and/or overlaid by the imaginglogic 138 to be conveyed to a medical practitioner via the display 146of the imaging system 142.

The control circuit 132 can have a variety of configurations. FIG. 5illustrates one embodiment of a control circuit 170 that can be used asthe control circuit 132 configured to control aspects of the surgicalvisualization system 100. The control circuit 170 is configured toimplement various processes described herein. The control circuit 170includes a microcontroller that includes a processor 172 (e.g., amicroprocessor or microcontroller) operably coupled to a memory 174. Thememory 174 is configured to store machine-executable instructions that,when executed by the processor 172, cause the processor 172 to executemachine instructions to implement various processes described herein.The processor 172 can be any one of a number of single-core or multicoreprocessors known in the art. The memory 174 can include volatile andnon-volatile storage media. The processor 172 includes an instructionprocessing unit 176 and an arithmetic unit 178. The instructionprocessing unit 176 is configured to receive instructions from thememory 174.

The surface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141 canhave a variety of configurations. FIG. 6 illustrates one embodiment of acombinational logic circuit 180 configured to control aspects of thesurgical visualization system 100 using logic such as one or more of thesurface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141. Thecombinational logic circuit 180 includes a finite state machine thatincludes a combinational logic 182 configured to receive data associatedwith a surgical device (e.g. the surgical device 102 and/or the imagingdevice 120) at an input 184, process the data by the combinational logic182, and provide an output 184 to a control circuit (e.g., the controlcircuit 132).

FIG. 7 illustrates one embodiment of a sequential logic circuit 190configured to control aspects of the surgical visualization system 100using logic such as one or more of the surface mapping logic 136, theimaging logic 138, the tissue identification logic 140, and the distancedetermining logic 141. The sequential logic circuit 190 includes afinite state machine that includes a combinational logic 192, a memory194, and a clock 196. The memory 194 is configured to store a currentstate of the finite state machine. The sequential logic circuit 190 canbe synchronous or asynchronous. The combinational logic 192 isconfigured to receive data associated with a surgical device (e.g. thesurgical device 102 and/or the imaging device 120) at an input 426,process the data by the combinational logic 192, and provide an output499 to a control circuit (e.g., the control circuit 132). In someembodiments, the sequential logic circuit 190 can include a combinationof a processor (e.g., processor 172 of FIG. 5 ) and a finite statemachine to implement various processes herein. In some embodiments, thefinite state machine can include a combination of a combinational logiccircuit (e.g., the combinational logic circuit 192 of FIG. 7 ) and thesequential logic circuit 190.

FIG. 8 illustrates another embodiment of a surgical visualization system200. The surgical visualization system 200 is generally configured andused similar to the surgical visualization system 100 of FIG. 1 , e.g.,includes a surgical device 202 and an imaging device 220. The imagingdevice 220 includes a spectral light emitter 223 configured to emitspectral light in a plurality of wavelengths to obtain a spectral imageof hidden structures, for example. The imaging device 220 can alsoinclude a three-dimensional camera and associated electronic processingcircuits. The surgical visualization system 200 is shown being utilizedintraoperatively to identify and facilitate avoidance of certaincritical structures, such as a ureter 201 a and vessels 201 b, in anorgan 203 (a uterus in this embodiment) that are not visible on asurface 205 of the organ 203.

The surgical visualization system 200 is configured to determine anemitter-to-tissue distance d_(e) from an emitter 206 on the surgicaldevice 202 to the surface 205 of the uterus 203 via structured light.The surgical visualization system 200 is configured to extrapolate adevice-to-tissue distance d_(t) from the surgical device 202 to thesurface 205 of the uterus 203 based on the emitter-to-tissue distanced_(e). The surgical visualization system 200 is also configured todetermine a tissue-to-ureter distance d_(A) from the ureter 201 a to thesurface 205 and a camera-to ureter distance d_(w) from the imagingdevice 220 to the ureter 201 a. As described herein, e.g., with respectto the surgical visualization system 100 of FIG. 1 , the surgicalvisualization system 200 is configured to determine the distance d_(w)with spectral imaging and time-of-flight sensors, for example. Invarious embodiments, the surgical visualization system 200 can determine(e.g., triangulate) the tissue-to-ureter distance d_(A) (or depth) basedon other distances and/or the surface mapping logic described herein.

As mentioned above, a surgical visualization system includes a controlsystem configured to control various aspects of the surgicalvisualization system. The control system can have a variety ofconfigurations. FIG. 9 illustrates one embodiment of a control system600 for a surgical visualization system, such as the surgicalvisualization system 100 of FIG. 1 , the surgical visualization system200 of FIG. 8 , or other surgical visualization system described herein.The control system 600 is a conversion system that integrates spectralsignature tissue identification and structured light tissue positioningto identify a critical structure, especially when those structure(s) areobscured by tissue, e.g., by fat, connective tissue, blood tissue,and/or organ(s), and/or by blood, and/or to detect tissue variability,such as differentiating tumors and/or non-healthy tissue from healthytissue within an organ.

The control system 600 is configured for implementing a hyperspectralimaging and visualization system in which a molecular response isutilized to detect and identify anatomy in a surgical field of view. Thecontrol system 600 includes a conversion logic circuit 648 configured toconvert tissue data to usable information for surgeons and/or othermedical practitioners. For example, variable reflectance based onwavelengths with respect to obscuring material can be utilized toidentify the critical structure in the anatomy. Moreover, the controlsystem 600 is configured to combine the identified spectral signatureand the structural light data in an image. For example, the controlsystem 600 can be employed to create of three-dimensional data set forsurgical use in a system with augmentation image overlays. Techniquescan be employed both intraoperatively and preoperatively usingadditional visual information. In various embodiments, the controlsystem 600 is configured to provide warnings to a medical practitionerwhen in the proximity of one or more critical structures. Variousalgorithms can be employed to guide robotic automation andsemi-automated approaches based on the surgical procedure and proximityto the critical structure(s).

A projected array of lights is employed by the control system 600 todetermine tissue shape and motion intraoperatively. Alternatively, flashLidar may be utilized for surface mapping of the tissue.

The control system 600 is configured to detect the critical structure,which as mentioned above can include one or more critical structures,and provide an image overlay of the critical structure and measure thedistance to the surface of the visible tissue and the distance to theembedded/buried critical structure(s). The control system 600 canmeasure the distance to the surface of the visible tissue or detect thecritical structure and provide an image overlay of the criticalstructure.

The control system 600 includes a spectral control circuit 602. Thespectral control circuit 602 can be a field programmable gate array(FPGA) or another suitable circuit configuration, such as theconfigurations described with respect to FIG. 6 , FIG. 7 , and FIG. 8 .The spectral control circuit 602 includes a processor 604 configured toreceive video input signals from a video input processor 606. Theprocessor 604 can be configured for hyperspectral processing and canutilize C/C++ code, for example. The video input processor 606 isconfigured to receive video-in of control (metadata) data such asshutter time, wave length, and sensor analytics, for example. Theprocessor 604 is configured to process the video input signal from thevideo input processor 606 and provide a video output signal to a videooutput processor 608, which includes a hyperspectral video-out ofinterface control (metadata) data, for example. The video outputprocessor 608 is configured to provides the video output signal to animage overlay controller 610.

The video input processor 606 is operatively coupled to a camera 612 atthe patient side via a patient isolation circuit 614. The camera 612includes a solid state image sensor 634. The patient isolation circuit614 can include a plurality of transformers so that the patient isisolated from other circuits in the system. The camera 612 is configuredto receive intraoperative images through optics 632 and the image sensor634. The image sensor 634 can include a CMOS image sensor, for example,or can include another image sensor technology, such as those discussedherein in connection with FIG. 4 . The camera 612 is configured tooutput 613 images in 14 bit/pixel signals. A person skilled in the artwill appreciate that higher or lower pixel resolutions can be employed.The isolated camera output signal 613 is provided to a color RGB fusioncircuit 616, which in this illustrated embodiment employs a hardwareregister 618 and a Nios2 co-processor 620 configured to process thecamera output signal 613. A color RGB fusion output signal is providedto the video input processor 606 and a laser pulsing control circuit622.

The laser pulsing control circuit 622 is configured to control a laserlight engine 624. The laser light engine 624 is configured to outputlight in a plurality of wavelengths (λ1, λ2, λ3 . . . λn) including nearinfrared (NIR). The laser light engine 624 can operate in a plurality ofmodes. For example, the laser light engine 624 can operate in two modes.In a first mode, e.g., a normal operating mode, the laser light engine624 is configured to output an illuminating signal. In a second mode,e.g., an identification mode, the laser light engine 624 is configuredto output RGBG and NIR light. In various embodiments, the laser lightengine 624 can operate in a polarizing mode.

Light output 626 from the laser light engine 624 is configured toilluminate targeted anatomy in an intraoperative surgical site 627. Thelaser pulsing control circuit 622 is also configured to control a laserpulse controller 628 for a laser pattern projector 630 configured toproject a laser light pattern 631, such as a grid or pattern of linesand/or dots, at a predetermined wavelength (λ2) on an operative tissueor organ at the surgical site 627. The camera 612 is configured toreceive the patterned light as well as the reflected light outputthrough the camera optics 632. The image sensor 634 is configured toconvert the received light into a digital signal.

The color RGB fusion circuit 616 is also configured to output signals tothe image overlay controller 610 and a video input module 636 forreading the laser light pattern 631 projected onto the targeted anatomyat the surgical site 627 by the laser pattern projector 630. Aprocessing module 638 is configured to process the laser light pattern631 and output a first video output signal 640 representative of thedistance to the visible tissue at the surgical site 627. The data isprovided to the image overlay controller 610. The processing module 638is also configured to output a second video signal 642 representative ofa three-dimensional rendered shape of the tissue or organ of thetargeted anatomy at the surgical site.

The first and second video output signals 640, 642 include datarepresentative of the position of the critical structure on athree-dimensional surface model, which is provided to an integrationmodule 643. In combination with data from the video out processor 608 ofthe spectral control circuit 602, the integration module 643 isconfigured to determine the distance (e.g., distance d_(A) of FIG. 1 )to a buried critical structure (e.g., via triangularization algorithms644), and the distance to the buried critical structure can be providedto the image overlay controller 610 via a video out processor 646. Theforegoing conversion logic can encompass the conversion logic circuit648 intermediate video monitors 652 and the camera 624/laser patternprojector 630 positioned at the surgical site 627.

Preoperative data 650, such as from a CT or MRI scan, can be employed toregister or align certain three-dimensional deformable tissue in variousinstances. Such preoperative data 650 can be provided to the integrationmodule 643 and ultimately to the image overlay controller 610 so thatsuch information can be overlaid with the views from the camera 612 andprovided to the video monitors 652. Embodiments of registration ofpreoperative data are further described in U.S. Pat. Pub. No.2020/0015907 entitled “Integration Of Imaging Data” filed Sep. 11, 2018,which is hereby incorporated by reference herein in its entirety.

The video monitors 652 are configured to output the integrated/augmentedviews from the image overlay controller 610. A medical practitioner canselect and/or toggle between different views on one or more displays. Ona first display 652 a, which is a monitor in this illustratedembodiment, the medical practitioner can toggle between (A) a view inwhich a three-dimensional rendering of the visible tissue is depictedand (B) an augmented view in which one or more hidden criticalstructures are depicted over the three-dimensional rendering of thevisible tissue. On a second display 652 b, which is a monitor in thisillustrated embodiment, the medical practitioner can toggle on distancemeasurements to one or more hidden critical structures and/or thesurface of visible tissue, for example.

The various surgical visualization systems described herein can beutilized to visualize various different types of tissues and/oranatomical structures, including tissues and/or anatomical structuresthat may be obscured from being visualized by EMR in the visible portionof the spectrum. The surgical visualization system can utilize aspectral imaging system, as mentioned above, which can be configured tovisualize different types of tissues based upon their varyingcombinations of constituent materials. In particular, a spectral imagingsystem can be configured to detect the presence of various constituentmaterials within a tissue being visualized based on the absorptioncoefficient of the tissue across various EMR wavelengths. The spectralimaging system can be configured to characterize the tissue type of thetissue being visualized based upon the particular combination ofconstituent materials.

FIG. 10 shows a graph 300 depicting how the absorption coefficient ofvarious biological materials varies across the EMR wavelength spectrum.In the graph 300, the vertical axis 302 represents absorptioncoefficient of the biological material in cm⁻¹, and the horizontal axis304 represents EMR wavelength in μm. A first line 306 in the graph 300represents the absorption coefficient of water at various EMRwavelengths, a second line 308 represents the absorption coefficient ofprotein at various EMR wavelengths, a third line 310 represents theabsorption coefficient of melanin at various EMR wavelengths, a fourthline 312 represents the absorption coefficient of deoxygenatedhemoglobin at various EMR wavelengths, a fifth line 314 represents theabsorption coefficient of oxygenated hemoglobin at various EMRwavelengths, and a sixth line 316 represents the absorption coefficientof collagen at various EMR wavelengths. Different tissue types havedifferent combinations of constituent materials and, therefore, thetissue type(s) being visualized by a surgical visualization system canbe identified and differentiated between according to the particularcombination of detected constituent materials. Accordingly, a spectralimaging system of a surgical visualization system can be configured toemit EMR at a number of different wavelengths, determine the constituentmaterials of the tissue based on the detected absorption EMR absorptionresponse at the different wavelengths, and then characterize the tissuetype based on the particular detected combination of constituentmaterials.

FIG. 11 shows an embodiment of the utilization of spectral imagingtechniques to visualize different tissue types and/or anatomicalstructures. In FIG. 11 , a spectral emitter 320 (e.g., the spectrallight source 150 of FIG. 4 ) is being utilized by an imaging system tovisualize a surgical site 322. The EMR emitted by the spectral emitter320 and reflected from the tissues and/or structures at the surgicalsite 322 is received by an image sensor (e.g., the image sensor 135 ofFIG. 4 ) to visualize the tissues and/or structures, which can be eithervisible (e.g., be located at a surface of the surgical site 322) orobscured (e.g., underlay other tissue and/or structures at the surgicalsite 322). In this embodiment, an imaging system (e.g., the imagingsystem 142 of FIG. 4 ) visualizes a tumor 324, an artery 326, andvarious abnormalities 328 (e.g., tissues not confirming to known orexpected spectral signatures) based upon the spectral signaturescharacterized by the differing absorptive characteristics (e.g.,absorption coefficient) of the constituent materials for each of thedifferent tissue/structure types. The visualized tissues and structurescan be displayed on a display screen associated with or coupled to theimaging system (e.g., the display 146 of the imaging system 142 of FIG.4 ), on a primary display (e.g., the primary display 819 of FIG. 19 ),on a non-sterile display (e.g., the non-sterile displays 807, 809 ofFIG. 19 ), on a display of a surgical hub (e.g., the display of thesurgical hub 806 of FIG. 19 ), on a device/instrument display, and/or onanother display.

The imaging system can be configured to tailor or update the displayedsurgical site visualization according to the identified tissue and/orstructure types. For example, as shown in FIG. 11 , the imaging systemcan display a margin 330 associated with the tumor 324 being visualizedon a display screen associated with or coupled to the imaging system, ona primary display, on a non-sterile display, on a display of a surgicalhub, on a device/instrument display, and/or on another display. Themargin 330 can indicate the area or amount of tissue that should beexcised to ensure complete removal of the tumor 324. The surgicalvisualization system's control system (e.g., the control system 133 ofFIG. 4 ) can be configured to control or update the dimensions of themargin 330 based on the tissues and/or structures identified by theimaging system. In this illustrated embodiment, the imaging system hasidentified multiple abnormalities 328 within the field of view (FOV).Accordingly, the control system can adjust the displayed margin 330 to afirst updated margin 332 having sufficient dimensions to encompass theabnormalities 328. Further, the imaging system has also identified theartery 326 partially overlapping with the initially displayed margin 330(as indicated by a highlighted region 334 of the artery 326).Accordingly, the control system can adjust the displayed margin to asecond updated margin 336 having sufficient dimensions to encompass therelevant portion of the artery 326.

Tissues and/or structures can also be imaged or characterized accordingto their reflective characteristics, in addition to or in lieu of theirabsorptive characteristics described above with respect to FIG. 10 andFIG. 11 , across the EMR wavelength spectrum. For example, FIG. 12 ,FIG. 13 , and FIG. 14 illustrate various graphs of reflectance ofdifferent types of tissues or structures across different EMRwavelengths. FIG. 12 is a graphical representation 340 of anillustrative ureter signature versus obscurants. FIG. 13 is a graphicalrepresentation 342 of an illustrative artery signature versusobscurants. FIG. 14 is a graphical representation 344 of an illustrativenerve signature versus obscurants. The plots in FIG. 12 , FIG. 13 , andFIG. 14 represent reflectance as a function of wavelength (nm) for theparticular structures (ureter, artery, and nerve) relative to thecorresponding reflectances of fat, lung tissue, and blood at thecorresponding wavelengths. These graphs are simply for illustrativepurposes and it should be understood that other tissues and/orstructures could have corresponding detectable reflectance signaturesthat would allow the tissues and/or structures to be identified andvisualized.

Select wavelengths for spectral imaging can be identified and utilizedbased on the anticipated critical structures and/or obscurants at asurgical site (e.g., “selective spectral” imaging). By utilizingselective spectral imaging, the amount of time required to obtain thespectral image can be minimized such that the information can beobtained in real-time and utilized intraoperatively. The wavelengths canbe selected by a medical practitioner or by a control circuit based oninput by a user, e.g., a medical practitioner. In certain instances, thewavelengths can be selected based on machine learning and/or big dataaccessible to the control circuit via, e.g., a cloud or surgical hub.

FIG. 15 illustrates one embodiment of spectral imaging to tissue beingutilized intraoperatively to measure a distance between a waveformemitter and a critical structure that is obscured by tissue. FIG. 15shows an embodiment of a time-of-flight sensor system 404 utilizingwaveforms 424, 425. The time-of-flight sensor system 404 can beincorporated into a surgical visualization system, e.g., as the sensorsystem 104 of the surgical visualization system 100 of FIG. 1 . Thetime-of-flight sensor system 404 includes a waveform emitter 406 and awaveform receiver 408 on the same surgical device 402 (e.g., the emitter106 and the receiver 108 on the same surgical device 102 of FIG. 1 ).The emitted wave 400 extends to a critical structure 401 (e.g., thecritical structure 101 of FIG. 1 ) from the emitter 406, and thereceived wave 425 is reflected back to by the receiver 408 from thecritical structure 401. The surgical device 402 in this illustratedembodiment is positioned through a trocar 410 that extends into a cavity407 in a patient. Although the trocar 410 is used in this in thisillustrated embodiment, other trocars or other access devices can beused, or no access device may be used.

The waveforms 424, 425 are configured to penetrate obscuring tissue 403,such as by having wavelengths in the NIR or SWIR spectrum ofwavelengths. A spectral signal (e.g., hyperspectral, multispectral, orselective spectral) or a photoacoustic signal is emitted from theemitter 406, as shown by a first arrow 407 pointing distally, and canpenetrate the tissue 403 in which the critical structure 401 isconcealed. The emitted waveform 424 is reflected by the criticalstructure 401, as shown by a second arrow 409 pointing proximally. Thereceived waveform 425 can be delayed due to a distance d between adistal end of the surgical device 402 and the critical structure 401.The waveforms 424, 425 can be selected to target the critical structure401 within the tissue 403 based on the spectral signature of thecritical structure 401, as described herein. The emitter 406 isconfigured to provide a binary signal on and off, as shown in FIG. 16 ,for example, which can be measured by the receiver 408.

Based on the delay between the emitted wave 424 and the received wave425, the time-of-flight sensor system 404 is configured to determine thedistance d. A time-of-flight timing diagram 430 for the emitter 406 andthe receiver 408 of FIG. 15 is shown in FIG. 16 . The delay is afunction of the distance d and the distance d is given by:

$d = {\frac{ct}{2} \cdot \frac{q_{2}}{q_{1} + q_{2}}}$

where c=the speed of light; t=length of pulse; q1=accumulated chargewhile light is emitted; and q2=accumulated charge while light is notbeing emitted.

The time-of-flight of the waveforms 424, 425 corresponds to the distanced in FIG. 15 . In various instances, additional emitters/receiversand/or pulsing signals from the emitter 406 can be configured to emit anon-penetrating signal. The non-penetrating signal can be configured todetermine the distance from the emitter 406 to the surface 405 of theobscuring tissue 403. In various instances, a depth of the criticalstructure 401 can be determined by:

d _(A) =d _(w) −d _(t)

where d_(A)=the depth of the critical structure 401; d_(w)=the distancefrom the emitter 406 to the critical structure 401 (d in FIG. 15 ); andd_(t)=the distance from the emitter 406 (on the distal end of thesurgical device 402) to the surface 405 of the obscuring tissue 403.

FIG. 17 illustrates another embodiment of a time-of-flight sensor system504 utilizing waves 524 a, 524 b, 524 c, 525 a, 525 b, 525 c is shown.The time-of-flight sensor system 504 can be incorporated into a surgicalvisualization system, e.g., as the sensor system 104 of the surgicalvisualization system 100 of FIG. 1 . The time-of-flight sensor system504 includes a waveform emitter 506 and a waveform receiver 508 (e.g.,the emitter 106 and the receiver 108 of FIG. 1 ). The waveform emitter506 is positioned on a first surgical device 502 a (e.g., the surgicaldevice 102 of FIG. 1 ), and the waveform receiver 508 is positioned on asecond surgical device 502 b. The surgical devices 502 a, 502 b arepositioned through first and second trocars 510 a, 510 b, respectively,which extend into a cavity 507 in a patient. Although the trocars 510 a,510 b are used in this in this illustrated embodiment, other trocars orother access devices can be used, or no access device may be used. Theemitted waves 524 a, 524 b, 524 c extend toward a surgical site from theemitter 506, and the received waves 525 a, 525 b, 525 c are reflectedback to the receiver 508 from various structures and/or surfaces at thesurgical site.

The different emitted waves 524 a, 524 b, 524 c are configured to targetdifferent types of material at the surgical site. For example, the wave524 a targets obscuring tissue 503, the wave 524 b targets a firstcritical structure 501 a (e.g., the critical structure 101 of FIG. 1 ),which is a vessel in this illustrated embodiment, and the wave 524 ctargets a second critical structure 501 b (e.g., the critical structure101 of FIG. 1 ), which is a cancerous tumor in this illustratedembodiment. The wavelengths of the waves 524 a, 524 b, 524 c can be inthe visible light, NIR, or SWIR spectrum of wavelengths. For example,visible light can be reflected off a surface 505 of the tissue 503, andNIR and/or SWIR waveforms can penetrate the surface 505 of the tissue503. In various aspects, as described herein, a spectral signal (e.g.,hyperspectral, multispectral, or selective spectral) or a photoacousticsignal can be emitted from the emitter 506. The waves 524 b, 524 c canbe selected to target the critical structures 501 a, 501 b within thetissue 503 based on the spectral signature of the critical structure 501a, 501 b, as described herein. Photoacoustic imaging is furtherdescribed in various U.S. patent applications, which are incorporated byreference herein in the present disclosure.

The emitted waves 524 a, 524 b, 524 c are reflected off the targetedmaterial, namely the surface 505, the first critical structure 501 a,and the second structure 501 b, respectively. The received waveforms 525a, 525 b, 525 c can be delayed due to distances d_(1a), d_(2a), d_(3a),d_(1b), d_(2b), d_(2c).

In the time-of-flight sensor system 504, in which the emitter 506 andthe receiver 508 are independently positionable (e.g., on separatesurgical devices 502 a, 502 b and/or controlled by separate roboticarms), the various distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c) can be calculated from the known position of the emitter 506 andthe receiver 508. For example, the positions can be known when thesurgical devices 502 a, 502 b are robotically-controlled. Knowledge ofthe positions of the emitter 506 and the receiver 508, as well as thetime of the photon stream to target a certain tissue and the informationreceived by the receiver 508 of that particular response can allow adetermination of the distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c). In one aspect, the distance to the obscured critical structures501 a, 501 b can be triangulated using penetrating wavelengths. Becausethe speed of light is constant for any wavelength of visible orinvisible light, the time-of-flight sensor system 504 can determine thevarious distances.

In a view provided to the medical practitioner, such as on a display,the receiver 508 can be rotated such that a center of mass of the targetstructure in the resulting images remains constant, e.g., in a planeperpendicular to an axis of a select target structure 503, 501 a, or 501b. Such an orientation can quickly communicate one or more relevantdistances and/or perspectives with respect to the target structure. Forexample, as shown in FIG. 17 , the surgical site is displayed from aviewpoint in which the critical structure 501 a is perpendicular to theviewing plane (e.g., the vessel is oriented in/out of the page). Such anorientation can be default setting; however, the view can be rotated orotherwise adjusted by a medical practitioner. In certain instances, themedical practitioner can toggle between different surfaces and/or targetstructures that define the viewpoint of the surgical site provided bythe imaging system.

As in this illustrated embodiment, the receiver 508 can be mounted onthe trocar 510 b (or other access device) through which the surgicaldevice 502 b is positioned. In other embodiments, the receiver 508 canbe mounted on a separate robotic arm for which the three-dimensionalposition is known. In various instances, the receiver 508 can be mountedon a movable arm that is separate from a robotic surgical system thatcontrols the surgical device 502 a or can be mounted to an operatingroom (OR) table or fixture that is intraoperatively registerable to therobot coordinate plane. In such instances, the position of the emitter506 and the receiver 508 can be registerable to the same coordinateplane such that the distances can be triangulated from outputs from thetime-of-flight sensor system 504.

Combining time-of-flight sensor systems and near-infrared spectroscopy(NIRS), termed TOF-NIRS, which is capable of measuring the time-resolvedprofiles of NIR light with nanosecond resolution can be found in“Time-Of-Flight Near-Infrared Spectroscopy For NondestructiveMeasurement Of Internal Quality In Grapefruit,” Journal of the AmericanSociety for Horticultural Science, May 2013 vol. 138 no. 3 225-228,which is hereby incorporated by reference in its entirety.

Embodiments of visualization systems and aspects and uses thereof aredescribed further in U.S. Pat. Pub. No. 2020/0015923 entitled “SurgicalVisualization Platform” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015900 entitled “Controlling An Emitter Assembly Pulse Sequence”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015668 entitled “SingularEMR Source Emitter Assembly” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015925 entitled “Combination Emitter And Camera Assembly” filedSep. 11, 2018, U.S. Pat. Pub. No. 2020/00015899 entitled “SurgicalVisualization With Proximity Tracking Features” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/00015903 entitled “Surgical Visualization OfMultiple Targets” filed Sep. 11, 2018, U.S. Pat. No. 10,792,034 entitled“Visualization Of Surgical Devices” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015897 entitled “Operative Communication Of Light” filed Sep.11, 2018, U.S. Pat. Pub. No. 2020/0015924 entitled “Robotic LightProjection Tools” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015898entitled “Surgical Visualization Feedback System” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/0015906 entitled “Surgical Visualization AndMonitoring” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015907entitled “Integration Of Imaging Data” filed Sep. 11, 2018, U.S. Pat.No. 10,925,598 entitled “Robotically-Assisted Surgical Suturing Systems”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015901 entitled “SafetyLogic For Surgical Suturing Systems” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015914 entitled “Robotic Systems With Separate PhotoacousticReceivers” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015902 entitled“Force Sensor Through Structured Light Deflection” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2019/0201136 entitled “Method Of Hub Communication”filed Dec. 4, 2018, U.S. patent application Ser. No. 16/729,772 entitled“Analyzing Surgical Trends By A Surgical System” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,747 entitled “Dynamic SurgicalVisualization Systems” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,744 entitled “Visualization Systems Using Structured Light”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,778entitled “System And Method For Determining, Adjusting, And ManagingResection Margin About A Subject Tissue” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,729 entitled “Surgical Systems ForProposing And Corroborating Organ Portion Removals” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,778 entitled “Surgical SystemFor Overlaying Surgical Instrument Data Onto A Virtual Three DimensionalConstruct Of An Organ” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,751 entitled “Surgical Systems For Generating ThreeDimensional Constructs Of Anatomical Organs And Coupling IdentifiedAnatomical Structures Thereto” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,740 entitled “Surgical Systems CorrelatingVisualization Data And Powered Surgical Instrument Data” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,737 entitled “AdaptiveSurgical System Control According To Surgical Smoke CloudCharacteristics” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,807 entitled “Method Of Using Imaging Devices In Surgery”filed Dec. 30, 2019, U.S. Prov. Pat. App. No. 63/249,652 entitled“Surgical Devices, Systems, and Methods Using Fiducial Identificationand Tracking” filed on Sep. 29, 2021, U.S. Prov. Pat. App. No.63/249,658 entitled “Surgical Devices, Systems, and Methods for Controlof One Visualization with Another” filed on Sep. 29, 2021, U.S. Prov.Pat. App. No. 63/249,870 entitled “Methods and Systems for ControllingCooperative Surgical Instruments” filed on Sep. 29, 2021, U.S. Prov.Pat. App. No. 63/249,881 entitled “Methods and Systems for ControllingCooperative Surgical Instruments with Variable Surgical Site AccessTrajectories” filed on Sep. 29, 2021, U.S. Prov. Pat. App. No.63/249,877 entitled “Methods and Systems for Controlling CooperativeSurgical Instruments” filed on Sep. 29, 2021, and U.S. Prov. Pat. App.No. 63/249,980 entitled “Cooperative Access” filed on Sep. 29, 2021,which are hereby incorporated by reference in their entireties.

Surgical Hubs

The various visualization or imaging systems described herein can beincorporated into a system that includes a surgical hub. In general, asurgical hub can be a component of a comprehensive digital medicalsystem capable of spanning multiple medical facilities and configured toprovide integrated and comprehensive improved medical care to a vastnumber of patients. The comprehensive digital medical system includes acloud-based medical analytics system that is configured to interconnectto multiple surgical hubs located across many different medicalfacilities. The surgical hubs are configured to interconnect with one ormore elements, such as one or more surgical instruments that are used toconduct medical procedures on patients and/or one or more visualizationsystems that are used during performance of medical procedures. Thesurgical hubs provide a wide array of functionality to improve theoutcomes of medical procedures. The data generated by the varioussurgical devices, visualization systems, and surgical hubs about thepatient and the medical procedure may be transmitted to the cloud-basedmedical analytics system. This data may then be aggregated with similardata gathered from many other surgical hubs, visualization systems, andsurgical instruments located at other medical facilities. Variouspatterns and correlations may be found through the cloud-based analyticssystem analyzing the collected data. Improvements in the techniques usedto generate the data may be generated as a result, and theseimprovements may then be disseminated to the various surgical hubs,visualization systems, and surgical instruments. Due to theinterconnectedness of all of the aforementioned components, improvementsin medical procedures and practices may be found that otherwise may notbe found if the many components were not so interconnected.

Examples of surgical hubs configured to receive, analyze, and outputdata, and methods of using such surgical hubs, are further described inU.S. Pat. Pub. No. 2019/0200844 entitled “Method Of Hub Communication,Processing, Storage And Display” filed Dec. 4, 2018, U.S. Pat. Pub. No.2019/0200981 entitled “Method Of Compressing Tissue Within A StaplingDevice And Simultaneously Displaying The Location Of The Tissue WithinThe Jaws” filed Dec. 4, 2018, U.S. Pat. Pub. No. 2019/0201046 entitled“Method For Controlling Smart Energy Devices” filed Dec. 4, 2018, U.S.Pat. Pub. No. 2019/0201114 entitled “Adaptive Control Program UpdatesFor Surgical Hubs” filed Mar. 29, 2018, U.S. Pat. Pub. No. 2019/0201140entitled “Surgical Hub Situational Awareness” filed Mar. 29, 2018, U.S.Pat. Pub. No. 2019/0206004 entitled “Interactive Surgical Systems WithCondition Handling Of Devices And Data Capabilities” filed Mar. 29,2018, U.S. Pat. Pub. No. 2019/0206555 entitled “Cloud-based MedicalAnalytics For Customization And Recommendations To A User” filed Mar.29, 2018, and U.S. Pat. Pub. No. 2019/0207857 entitled “Surgical NetworkDetermination Of Prioritization Of Communication, Interaction, OrProcessing Based On System Or Device Needs” filed Nov. 6, 2018, whichare hereby incorporated by reference in their entireties.

FIG. 18 illustrates one embodiment of a computer-implemented interactivesurgical system 700 that includes one or more surgical systems 702 and acloud-based system (e.g., a cloud 704 that can include a remote server713 coupled to a storage device 705). Each surgical system 702 includesat least one surgical hub 706 in communication with the cloud 704. Inone example, as illustrated in FIG. 18 , the surgical system 702includes a visualization system 708, a robotic system 710, and anintelligent (or “smart”) surgical instrument 712, which are configuredto communicate with one another and/or the hub 706. The intelligentsurgical instrument 712 can include imaging device(s). The surgicalsystem 702 can include an M number of hubs 706, an N number ofvisualization systems 708, an O number of robotic systems 710, and a Pnumber of intelligent surgical instruments 712, where M, N, O, and P areintegers greater than or equal to one that may or may not be equal toany one or more of each other. Various exemplary intelligent surgicalinstruments and robotic systems are described herein.

Data received by a surgical hub from a surgical visualization system canbe used in any of a variety of ways. In an exemplary embodiment, thesurgical hub can receive data from a surgical visualization system inuse with a patient in a surgical setting, e.g., in use in an operatingroom during performance of a surgical procedure. The surgical hub canuse the received data in any of one or more ways, as discussed herein.

The surgical hub can be configured to analyze received data in real timewith use of the surgical visualization system and adjust control one ormore of the surgical visualization system and/or one or more intelligentsurgical instruments in use with the patient based on the analysis ofthe received data. Such adjustment can include, for example, adjustingone or operational control parameters of intelligent surgicalinstrument(s), causing one or more sensors of one or more intelligentsurgical instruments to take a measurement to help gain an understandingof the patient's current physiological condition, and/or currentoperational status of an intelligent surgical instrument, and otheradjustments. Controlling and adjusting operation of intelligent surgicalinstruments is discussed further below. Examples of operational controlparameters of an intelligent surgical instrument include motor speed,cutting element speed, time, duration, level of energy application, andlight emission. Examples of surgical hubs and of controlling andadjusting intelligent surgical instrument operation are describedfurther in previously mentioned U.S. patent application Ser. No.16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019, and in U.S. patent application Ser. No.17/068,857 entitled “Adaptive Responses From Smart Packaging Of DrugDelivery Absorbable Adjuncts” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,858 entitled “Drug Administration DevicesThat Communicate With Surgical Hubs” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,859 entitled “Controlling Operation Of DrugAdministration Devices Using Surgical Hubs” filed Oct. 13, 2020, U.S.patent application Ser. No. 17/068,863 entitled “Patient MonitoringUsing Drug Administration Devices” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,865 entitled “Monitoring And CommunicatingInformation Using Drug Administration Devices” filed Oct. 13, 2020, andU.S. patent application Ser. No. 17/068,867 entitled “Aggregating AndAnalyzing Drug Administration Data” filed Oct. 13, 2020, which arehereby incorporated by reference in their entireties.

The surgical hub can be configured to cause visualization of thereceived data to be provided in the surgical setting on a display sothat a medical practitioner in the surgical setting can view the dataand thereby receive an understanding of the operation of the imagingdevice(s) in use in the surgical setting. Such information provided viavisualization can include text and/or images.

FIG. 19 illustrates one embodiment of a surgical system 802 including asurgical hub 806 (e.g., the surgical hub 706 of FIG. 18 or othersurgical hub described herein), a robotic surgical system 810 (e.g., therobotic surgical system 110 of FIG. 1 or other robotic surgical systemherein), and a visualization system 808 (e.g., the visualization system100 of FIG. 1 or other visualization system described herein). Thesurgical hub 806 can be in communication with a cloud, as discussedherein. FIG. 19 shows the surgical system 802 being used to perform asurgical procedure on a patient who is lying down on an operating table814 in a surgical operating room 816. The robotic system 810 includes asurgeon's console 818, a patient side cart 820 (surgical robot), and arobotic system surgical hub 822. The robotic system surgical hub 822 isgenerally configured similar to the surgical hub 822 and can be incommunication with a cloud. In some embodiments, the robotic systemsurgical hub 822 and the surgical hub 806 can be combined. The patientside cart 820 can manipulate an intelligent surgical tool 812 through aminimally invasive incision in the body of the patient while a medicalpractitioner, e.g., a surgeon, nurse, and/or other medical practitioner,views the surgical site through the surgeon's console 818. An image ofthe surgical site can be obtained by an imaging device 824 (e.g., theimaging device 120 of FIG. 1 or other imaging device described herein),which can be manipulated by the patient side cart 820 to orient theimaging device 824. The robotic system surgical hub 822 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 818.

A primary display 819 is positioned in the sterile field of theoperating room 816 and is configured to be visible to an operator at theoperating table 814. In addition, as in this illustrated embodiment, avisualization tower 818 can positioned outside the sterile field. Thevisualization tower 818 includes a first non-sterile display 807 and asecond non-sterile display 809, which face away from each other. Thevisualization system 808, guided by the surgical hub 806, is configuredto utilize the displays 807, 809, 819 to coordinate information flow tomedical practitioners inside and outside the sterile field. For example,the surgical hub 806 can cause the visualization system 808 to display asnapshot and/or a video of a surgical site, as obtained by the imagingdevice 824, on one or both of the non-sterile displays 807, 809, whilemaintaining a live feed of the surgical site on the primary display 819.The snapshot and/or video on the non-sterile display 807 and/or 809 canpermit a non-sterile medical practitioner to perform a diagnostic steprelevant to the surgical procedure, for example.

The surgical hub 806 is configured to route a diagnostic input orfeedback entered by a non-sterile medical practitioner at thevisualization tower 818 to the primary display 819 within the sterilefield, where it can be viewed by a sterile medical practitioner at theoperating table 814. For example, the input can be in the form of amodification to the snapshot and/or video displayed on the non-steriledisplay 807 and/or 809, which can be routed to the primary display 819by the surgical hub 806.

The surgical hub 806 is configured to coordinate information flow to adisplay of the intelligent surgical instrument 812, as is described invarious U.S. Patent Applications that are incorporated by referenceherein in the present disclosure. A diagnostic input or feedback enteredby a non-sterile operator at the visualization tower 818 can be routedby the surgical hub 806 to the display 819 within the sterile field,where it can be viewed by the operator of the surgical instrument 812and/or by other medical practitioner(s) in the sterile field.

The intelligent surgical instrument 812 and the imaging device 824,which is also an intelligent surgical tool, is being used with thepatient in the surgical procedure as part of the surgical system 802.Other intelligent surgical instruments 812 a that can be used in thesurgical procedure, e.g., that can be removably coupled to the patientside cart 820 and be in communication with the robotic surgical system810 and the surgical hub 806, are also shown in FIG. 19 as beingavailable. Non-intelligent (or “dumb”) surgical instruments 817, e.g.,scissors, trocars, cannulas, scalpels, etc., that cannot be incommunication with the robotic surgical system 810 and the surgical hub806 are also shown in FIG. 19 as being available for use.

Operating Intelligent Surgical Instruments

An intelligent surgical device can have an algorithm stored thereon,e.g., in a memory thereof, configured to be executable on board theintelligent surgical device, e.g., by a processor thereof, to controloperation of the intelligent surgical device. In some embodiments,instead of or in addition to being stored on the intelligent surgicaldevice, the algorithm can be stored on a surgical hub, e.g., in a memorythereof, that is configured to communicate with the intelligent surgicaldevice.

The algorithm is stored in the form of one or more sets of pluralitiesof data points defining and/or representing instructions, notifications,signals, etc. to control functions of the intelligent surgical device.In some embodiments, data gathered by the intelligent surgical devicecan be used by the intelligent surgical device, e.g., by a processor ofthe intelligent surgical device, to change at least one variableparameter of the algorithm. As discussed above, a surgical hub can be incommunication with an intelligent surgical device, so data gathered bythe intelligent surgical device can be communicated to the surgical huband/or data gathered by another device in communication with thesurgical hub can be communicated to the surgical hub, and data can becommunicated from the surgical hub to the intelligent surgical device.Thus, instead of or in addition to the intelligent surgical device beingconfigured to change a stored variable parameter, the surgical hub canbe configured to communicate the changed at least one variable, alone oras part of the algorithm, to the intelligent surgical device and/or thesurgical hub can communicate an instruction to the intelligent surgicaldevice to change the at least one variable as determined by the surgicalhub.

The at least one variable parameter is among the algorithm's datapoints, e.g., are included in instructions for operating the intelligentsurgical device, and are thus each able to be changed by changing one ormore of the stored pluralities of data points of the algorithm. Afterthe at least one variable parameter has been changed, subsequentexecution of the algorithm is according to the changed algorithm. Assuch, operation of the intelligent surgical device over time can bemanaged for a patient to increase the beneficial results use of theintelligent surgical device by taking into consideration actualsituations of the patient and actual conditions and/or results of thesurgical procedure in which the intelligent surgical device is beingused. Changing the at least one variable parameter is automated toimprove patient outcomes. Thus, the intelligent surgical device can beconfigured to provide personalized medicine based on the patient and thepatient's surrounding conditions to provide a smart system. In asurgical setting in which the intelligent surgical device is being usedduring performance of a surgical procedure, automated changing of the atleast one variable parameter may allow for the intelligent surgicaldevice to be controlled based on data gathered during the performance ofthe surgical procedure, which may help ensure that the intelligentsurgical device is used efficiently and correctly and/or may help reducechances of patient harm by harming a critical anatomical structure.

The at least one variable parameter can be any of a variety of differentoperational parameters. Examples of variable parameters include motorspeed, motor torque, energy level, energy application duration, tissuecompression rate, jaw closure rate, cutting element speed, loadthreshold, etc.

FIG. 20 illustrates one embodiment of an intelligent surgical instrument900 including a memory 902 having an algorithm 904 stored therein thatincludes at least one variable parameter. The algorithm 904 can be asingle algorithm or can include a plurality of algorithms, e.g.,separate algorithms for different aspects of the surgical instrument'soperation, where each algorithm includes at least one variableparameter. The intelligent surgical instrument 900 can be the surgicaldevice 102 of FIG. 1 , the imaging device 120 of FIG. 1 , the surgicaldevice 202 of FIG. 8 , the imaging device 220 of FIG. 8 , the surgicaldevice 402 of FIG. 15 , the surgical device 502 a of FIG. 17 , thesurgical device 502 b of FIG. 17 , the surgical device 712 of FIG. 18 ,the surgical device 812 of FIG. 19 , the imaging device 824 of FIG. 19 ,or other intelligent surgical instrument. The surgical instrument 900also includes a processor 906 configured to execute the algorithm 904 tocontrol operation of at least one aspect of the surgical instrument 900.To execute the algorithm 904, the processor 906 is configured to run aprogram stored in the memory 902 to access a plurality of data points ofthe algorithm 904 in the memory 902.

The surgical instrument 900 also includes a communications interface908, e.g., a wireless transceiver or other wired or wirelesscommunications interface, configured to communicate with another device,such as a surgical hub 910. The communications interface 908 can beconfigured to allow one-way communication, such as providing data to aremote server (e.g., a cloud server or other server) and/or to a local,surgical hub server, and/or receiving instructions or commands from aremote server and/or a local, surgical hub server, or two-waycommunication, such as providing information, messages, data, etc.regarding the surgical instrument 900 and/or data stored thereon andreceiving instructions, such as from a doctor; a remote server regardingupdates to software; a local, surgical hub server regarding updates tosoftware; etc.

The surgical instrument 900 is simplified in FIG. 20 and can includeadditional components, e.g., a bus system, a handle, a elongate shafthaving an end effector at a distal end thereof, a power source, etc. Theprocessor 906 can also be configured to execute instructions stored inthe memory 902 to control the device 900 generally, including otherelectrical components thereof such as the communications interface 908,an audio speaker, a user interface, etc.

The processor 906 is configured to change at least one variableparameter of the algorithm 904 such that a subsequent execution of thealgorithm 904 will be in accordance with the changed at least onevariable parameter. To change the at least one variable parameter of thealgorithm 904, the processor 906 is configured to modify or update thedata point(s) of the at least one variable parameter in the memory 902.The processor 906 can be configured to change the at least one variableparameter of the algorithm 904 in real time with use of the surgicaldevice 900 during performance of a surgical procedure, which mayaccommodate real time conditions.

Additionally or alternatively to the processor 906 changing the at leastone variable parameter, the processor 906 can be configured to changethe algorithm 904 and/or at least one variable parameter of thealgorithm 904 in response to an instruction received from the surgicalhub 910. In some embodiments, the processor 906 is configured to changethe at least one variable parameter only after communicating with thesurgical hub 910 and receiving an instruction therefrom, which may helpensure coordinated action of the surgical instrument 900 with otheraspects of the surgical procedure in which the surgical instrument 900is being used.

In an exemplary embodiment, the processor 906 executes the algorithm 904to control operation of the surgical instrument 900, changes the atleast one variable parameter of the algorithm 904 based on real timedata, and executes the algorithm 904 after changing the at least onevariable parameter to control operation of the surgical instrument 900.

FIG. 21 illustrates one embodiment of a method 912 of using of thesurgical instrument 900 including a change of at least one variableparameter of the algorithm 904. The processor 906 controls 914 operationof the surgical instrument 900 by executing the algorithm 904 stored inthe memory 902. Based on any of this subsequently known data and/orsubsequently gathered data, the processor 904 changes 916 the at leastone variable parameter of the algorithm 904 as discussed above. Afterchanging the at least one variable parameter, the processor 906 controls918 operation of the surgical instrument 900 by executing the algorithm904, now with the changed at least one variable parameter. The processor904 can change 916 the at least one variable parameter any number oftimes during performance of a surgical procedure, e.g., zero, one, two,three, etc. During any part of the method 912, the surgical instrument900 can communicate with one or more computer systems, e.g., thesurgical hub 910, a remote server such as a cloud server, etc., usingthe communications interface 908 to provide data thereto and/or receiveinstructions therefrom.

Situational Awareness

Operation of an intelligent surgical instrument can be altered based onsituational awareness of the patient. The operation of the intelligentsurgical instrument can be altered manually, such as by a user of theintelligent surgical instrument handling the instrument differently,providing a different input to the instrument, ceasing use of theinstrument, etc. Additionally or alternatively, the operation of anintelligent surgical instrument can be changed automatically by analgorithm of the instrument being changed, e.g., by changing at leastone variable parameter of the algorithm. As mentioned above, thealgorithm can be adjusted automatically without user input requestingthe change. Automating the adjustment during performance of a surgicalprocedure may help save time, may allow medical practitioners to focuson other aspects of the surgical procedure, and/or may ease the processof using the surgical instrument for a medical practitioner, which eachmay improve patient outcomes, such as by avoiding a critical structure,controlling the surgical instrument with consideration of a tissue typethe instrument is being used on and/or near, etc.

The visualization systems described herein can be utilized as part of asituational awareness system that can be embodied or executed by asurgical hub, e.g., the surgical hub 706, the surgical hub 806, or othersurgical hub described herein. In particular, characterizing,identifying, and/or visualizing surgical instruments (including theirpositions, orientations, and actions), tissues, structures, users,and/or other things located within the surgical field or the operatingtheater can provide contextual data that can be utilized by asituational awareness system to infer various information, such as atype of surgical procedure or a step thereof being performed, a type oftissue(s) and/or structure(s) being manipulated by a surgeon or othermedical practitioner, and other information. The contextual data canthen be utilized by the situational awareness system to provide alertsto a user, suggest subsequent steps or actions for the user toundertake, prepare surgical devices in anticipation for their use (e.g.,activate an electrosurgical generator in anticipation of anelectrosurgical instrument being utilized in a subsequent step of thesurgical procedure, etc.), control operation of intelligent surgicalinstruments (e.g., customize surgical instrument operational parametersof an algorithm as discussed further below), and so on.

Although an intelligent surgical device including an algorithm thatresponds to sensed data, e.g., by having at least one variable parameterof the algorithm changed, can be an improvement over a “dumb” devicethat operates without accounting for sensed data, some sensed data canbe incomplete or inconclusive when considered in isolation, e.g.,without the context of the type of surgical procedure being performed orthe type of tissue that is being operated on. Without knowing theprocedural context (e.g., knowing the type of tissue being operated onor the type of procedure being performed), the algorithm may control thesurgical device incorrectly or sub-optimally given the particularcontext-free sensed data. For example, the optimal manner for analgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing, ease of being cut,etc.) and thus respond differently to actions taken by surgicalinstruments. Therefore, it may be desirable for a surgical instrument totake different actions even when the same measurement for a particularparameter is sensed. As one example, the optimal manner in which tocontrol a surgical stapler in response to the surgical stapler sensingan unexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, thesurgical instrument's control algorithm would optimally ramp down themotor in response to an unexpectedly high force to close to avoidtearing the tissue, e.g., change a variable parameter controlling motorspeed or torque so the motor is slower. For tissues that are resistantto tearing, such as stomach tissue, the instrument's algorithm wouldoptimally ramp up the motor in response to an unexpectedly high force toclose to ensure that the end effector is clamped properly on the tissue,e.g., change a variable parameter controlling motor speed or torque sothe motor is faster. Without knowing whether lung or stomach tissue hasbeen clamped, the algorithm may be sub-optimally changed or not changedat all.

A surgical hub can be configured to derive information about a surgicalprocedure being performed based on data received from various datasources and then control modular devices accordingly. In other words,the surgical hub can be configured to infer information about thesurgical procedure from received data and then control the modulardevices operably coupled to the surgical hub based upon the inferredcontext of the surgical procedure. Modular devices can include anysurgical device that is controllable by a situational awareness system,such as visualization system devices (e.g., a camera, a display screen,etc.), smart surgical instruments (e.g., an ultrasonic surgicalinstrument, an electrosurgical instrument, a surgical stapler, smokeevacuators, scopes, etc.). A modular device can include sensor(s)sconfigured to detect parameters associated with a patient with which thedevice is being used and/or associated with the modular device itself.

The contextual information derived or inferred from the received datacan include, for example, a type of surgical procedure being performed,a particular step of the surgical procedure that the surgeon (or othermedical practitioner) is performing, a type of tissue being operated on,or a body cavity that is the subject of the surgical procedure. Thesituational awareness system of the surgical hub can be configured toderive the contextual information from the data received from the datasources in a variety of different ways. In an exemplary embodiment, thecontextual information received by the situational awareness system ofthe surgical hub is associated with a particular control adjustment orset of control adjustments for one or more modular devices. The controladjustments each correspond to a variable parameter. In one example, thesituational awareness system includes a pattern recognition system, ormachine learning system (e.g., an artificial neural network), that hasbeen trained on training data to correlate various inputs (e.g., datafrom databases, patient monitoring devices, and/or modular devices) tocorresponding contextual information regarding a surgical procedure. Inother words, a machine learning system can be trained to accuratelyderive contextual information regarding a surgical procedure from theprovided inputs. In another example, the situational awareness systemcan include a lookup table storing pre-characterized contextualinformation regarding a surgical procedure in association with one ormore inputs (or ranges of inputs) corresponding to the contextualinformation. In response to a query with one or more inputs, the lookuptable can return the corresponding contextual information for thesituational awareness system for controlling at least one modulardevice. In another example, the situational awareness system includes afurther machine learning system, lookup table, or other such system,which generates or retrieves one or more control adjustments for one ormore modular devices when provided the contextual information as input.

A surgical hub including a situational awareness system may provide anynumber of benefits for a surgical system. One benefit includes improvingthe interpretation of sensed and collected data, which would in turnimprove the processing accuracy and/or the usage of the data during thecourse of a surgical procedure. Another benefit is that the situationalawareness system for the surgical hub may improve surgical procedureoutcomes by allowing for adjustment of surgical instruments (and othermodular devices) for the particular context of each surgical procedure(such as adjusting to different tissue types) and validating actionsduring a surgical procedure. Yet another benefit is that the situationalawareness system may improve surgeon's and/or other medicalpractitioners' efficiency in performing surgical procedures byautomatically suggesting next steps, providing data, and adjustingdisplays and other modular devices in the surgical theater according tothe specific context of the procedure. Another benefit includesproactively and automatically controlling modular devices according tothe particular step of the surgical procedure that is being performed toreduce the number of times that medical practitioners are required tointeract with or control the surgical system during the course of asurgical procedure, such as by a situationally aware surgical hubproactively activating a generator to which an RF electrosurgicalinstrument is connected if it determines that a subsequent step of theprocedure requires the use of the instrument. Proactively activating theenergy source allows the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

For example, a situationally aware surgical hub can be configured todetermine what type of tissue is being operated on. Therefore, when anunexpectedly high force to close a surgical instrument's end effector isdetected, the situationally aware surgical hub can be configured tocorrectly ramp up or ramp down a motor of the surgical instrument forthe type of tissue, e.g., by changing or causing change of at least onevariable parameter of an algorithm for the surgical instrument regardingmotor speed or torque.

For another example, a type of tissue being operated can affectadjustments that are made to compression rate and load thresholds of asurgical stapler for a particular tissue gap measurement. Asituationally aware surgical hub can be configured to infer whether asurgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub to determine whether the tissueclamped by an end effector of the surgical stapler is lung tissue (for athoracic procedure) or stomach tissue (for an abdominal procedure). Thesurgical hub can then be configured to cause adjustment of thecompression rate and load thresholds of the surgical staplerappropriately for the type of tissue, e.g., by changing or causingchange of at least one variable parameter of an algorithm for thesurgical stapler regarding compression rate and load threshold.

As yet another example, a type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub can be configured to determinewhether the surgical site is under pressure (by determining that thesurgical procedure is utilizing insufflation) and determine theprocedure type. As a procedure type is generally performed in a specificbody cavity, the surgical hub can be configured to control a motor rateof the smoke evacuator appropriately for the body cavity being operatedin, e.g., by changing or causing change of at least one variableparameter of an algorithm for the smoke evacuator regarding motor rate.Thus, a situationally aware surgical hub may provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, a type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because an endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub canbe configured to determine whether the surgical procedure is anarthroscopic procedure. The surgical hub can be configured to adjust anRF power level or an ultrasonic amplitude of the generator (e.g., adjustenergy level) to compensate for the fluid filled environment, e.g., bychanging or causing change of at least one variable parameter of analgorithm for the instrument and/or a generator regarding energy level.Relatedly, a type of tissue being operated on can affect the optimalenergy level for an ultrasonic surgical instrument or RF electrosurgicalinstrument to operate at. A situationally aware surgical hub can beconfigured to determine what type of surgical procedure is beingperformed and then customize the energy level for the ultrasonicsurgical instrument or RF electrosurgical instrument, respectively,according to the expected tissue profile for the surgical procedure,e.g., by changing or causing change of at least one variable parameterof an algorithm for the instrument and/or a generator regarding energylevel. Furthermore, a situationally aware surgical hub can be configuredto adjust the energy level for the ultrasonic surgical instrument or RFelectrosurgical instrument throughout the course of a surgicalprocedure, rather than just on a procedure-by-procedure basis. Asituationally aware surgical hub can be configured to determine whatstep of the surgical procedure is being performed or will subsequentlybe performed and then update the control algorithm(s) for the generatorand/or ultrasonic surgical instrument or RF electrosurgical instrumentto set the energy level at a value appropriate for the expected tissuetype according to the surgical procedure step.

As another example, a situationally aware surgical hub can be configuredto determine whether the current or subsequent step of a surgicalprocedure requires a different view or degree of magnification on adisplay according to feature(s) at the surgical site that the surgeonand/or other medical practitioner is expected to need to view. Thesurgical hub can be configured to proactively change the displayed view(supplied by, e.g., an imaging device for a visualization system)accordingly so that the display automatically adjusts throughout thesurgical procedure.

As yet another example, a situationally aware surgical hub can beconfigured to determine which step of a surgical procedure is beingperformed or will subsequently be performed and whether particular dataor comparisons between data will be required for that step of thesurgical procedure. The surgical hub can be configured to automaticallycall up data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon or other medical practitionerto ask for the particular information.

As another example, a situationally aware surgical hub can be configuredto determine whether a surgeon and/or other medical practitioner ismaking an error or otherwise deviating from an expected course of actionduring the course of a surgical procedure, e.g., as provided in apre-operative surgical plan. For example, the surgical hub can beconfigured to determine a type of surgical procedure being performed,retrieve a corresponding list of steps or order of equipment usage(e.g., from a memory), and then compare the steps being performed or theequipment being used during the course of the surgical procedure to theexpected steps or equipment for the type of surgical procedure that thesurgical hub determined is being performed. The surgical hub can beconfigured to provide an alert (visual, audible, and/or tactile)indicating that an unexpected action is being performed or an unexpecteddevice is being utilized at the particular step in the surgicalprocedure.

In certain instances, operation of a robotic surgical system, such asany of the various robotic surgical systems described herein, can becontrolled by the surgical hub based on its situational awareness and/orfeedback from the components thereof and/or based on information from acloud (e.g., the cloud 713 of FIG. 18 ).

Embodiments of situational awareness systems and using situationalawareness systems during performance of a surgical procedure aredescribed further in previously mentioned U.S. patent application Ser.No. 16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019.

Integrated Anchoring Elements

In certain embodiments, surgical anchoring systems that are configuredfor endoluminal access and enable non-traumatic retraction ormanipulation of the surgical site to improve access thereto (e.g.,visual and/or operational purposes). Unlike conventional systems (e.g.,systems that use laparoscopically arranged instruments, such asgraspers, to grasp the fragile exterior tissue surfaces of an organ),the present surgical anchoring systems are designed to manipulate theorgan using anchor members, which not only have a larger surface areathan conventional graspers, but are also configured to apply amanipulation force to an inner tissue layer of an organ, which istypically tougher and less fragile than the organ's outer tissuelayer(s). This inner manipulation force can increase the mobilization ofan organ at a treatment site to thereby improve access and movement(e.g., for dissection and resection) without damaging the exteriortissue layer of an organ or reducing blood flow to the treatment site.The organ can include multiple natural body lumens (e.g., bronchioles ofa lung), whereas in other embodiments, the organ includes a singlenatural body lumen (e.g., a colon).

In one exemplary embodiment, the surgical anchor systems can include asurgical instrument configured for endoluminal access (e.g., anendoscope) that includes an outer sleeve defining a working channeltherethrough and at least one channel arm configured to extend throughthe working channel. The at least one channel arm includes at least oneanchor member coupled to the at least one channel arm and configured tomove between expanded and unexpanded states, and at least one controlactuator extending along the at least one channel arm and operativelycoupled to the at least one anchor member. The at least one controlactuator is also operatively coupled to a drive system that isconfigured to control motion of the at least one channel arm. The atleast one anchor member can be configured to be at least partiallydisposed within a natural body lumen such that, when in the expandedstate, the at least one anchor member can contact an inner surface ofthe natural body lumen and therefore anchor the at least one channel armto the natural body lumen. As a result, the motion of the channel armcan selectively manipulate the natural body lumen anchored thereto(e.g., internally manipulate) and consequently, the organ which isassociated with the natural body lumen.

In another exemplary embodiment, the surgical anchoring systems caninclude a surgical instrument configured for endoluminal access (e.g.,an endoscope) that includes dual coupled deployable fixation elements.The dual coupled deployable fixation elements are configured to interactwith both a fixed anatomical location and a moveable anatomical locationto manipulate and reposition an organ. The surgical instrument caninclude a first deployable fixation element that is deployed at anatural body orifice of the organ, which acts as a fixed anatomicallocation. The surgical instrument can include a second deployablefixation element that is deployed at a moveable anatomical locationspaced apart from the fixed anatomical location. The surgical instrumentcan be configured to manipulate and reposition the organ to improveaccess and visibility from the opposite side of the organ wall. Due tothe coupling of the first deployable fixation element to a fixedanatomical location, the forces and restraints of the fixed anatomicallocation can be communicated to the second first deployable fixationelement to allow for induced lateral forces and movements to the organ.

The term “expanded” is intended to mean that the anchor member(s)has/have increased in size in a desired amount through mechanical meansor fluid pressure. These terms are not intended to mean that the anchormember(s) is/are necessarily entirely or 100% filled with a fluid whenthe anchor member(s) are “expanded” (however, such embodiments arewithin the scope of the term “filled”). Similarly, the term “unexpanded”does not necessarily mean that the anchor member(s) is/are entirelyempty or at 0 pressure. There may be some fluid and the anchor member(s)may have a non-zero pressure in an “unexpanded” state. An “uninflated”anchor member(s) is/are intended to mean that the anchor member(s)is/are mechanically collapsed to a smaller size than the expanded size,or does/do not include fluid in an amount or at a pressure that would bedesired after the anchor member(s) is/are filled.

An exemplary surgical anchoring system can include a variety of featuresas described herein and illustrated in the drawings. However, a personskilled in the art will appreciate that the surgical anchoring systemscan include only some of these features and/or it can include a varietyof other features known in the art. The surgical anchoring systemsdescribed herein are merely intended to represent certain exemplaryembodiments. Moreover, while the surgical anchoring systems are shownand described in connection with a lung and a colon, a person skilled inthe art will appreciate that these surgical anchoring systems can beused in connection with any other suitable natural body lumens ororgans.

A lung resection (e.g., a lobectomy) is a surgical procedure in whichall or part (e.g., one or more lobes) of the lung is removed. Thepurpose of performing a lung resection is to treat a damaged or diseasedlung as a result of, for example, lung cancer, emphysema, orbronchiectasis. During a lung resection, the lung or lungs are firstdeflated, and thereafter one or more incisions are made on the patient'sside between the ribs to reach the lungs laparoscopically. Instruments,such as graspers and a laparoscope, are inserted through the incision.Once the infected or damaged area of the lung is identified, the area isdissected from the lung and removed from the one or more incisions. Thedissected area and the one or more incisions can be closed, for example,with a surgical stapler or stiches.

Since the lung is deflated during surgery, the lung, or certain portionsthereof, may need to be mobilized to allow the instruments to reach thesurgical site. This mobilization can be carried out by grasping theouter tissue layer of the lung with graspers and applying a force to thelung through the graspers. However, the pleura and parenchyma of thelung are very fragile and therefore can be easily ripped or torn underthe applied force. Additionally, during mobilization, the graspers cancut off blood supply to one or more areas of the lung.

FIG. 22 illustrates an exemplary embodiment of a surgical anchoringsystem 2100 that is configured for endoluminal access into a lung 2010.As will be described in more detail below, the surgical anchoring system2100 is used to manipulate a lung 2010 through contact with a naturalbody lumen (e.g., first bronchiole 2022) within the lung 2010. Forpurposes of simplicity, certain components of the surgical anchoringsystem 2100 and the lung 2010 are not illustrated.

As shown, the lung 2010 includes an outer tissue surface 2012, a trachea2014, a right bronchus 2016, and bronchioles 2018. The trachea 2014,right bronchus 2016, and the bronchioles 2018 are in fluid communicationwith each other. Additionally, the lung 2010 includes an upper lobe2020, which includes first bronchiole 2022, and a middle lobe 2023,which includes second bronchiole 2024. As illustrated in FIG. 22 , thelung 2010 is in an inflated state while the surgical anchoring system2100 is initially inserted into the lung 2010. When operating in thethoracic cavity, the lung 2010 is collapsed to provide sufficientworking space between the rib cage and the lungs such thatlaparoscopically arranged instruments can access and manipulate the lung2010. In use, as described in more detail below, the surgical anchoringsystem 2100 can manipulate (e.g., mobilize) a portion of the lung 2010.

The surgical anchoring system 2100 includes a surgical instrument 2102configured for endoluminal access through the trachea 2014 and into thelung 2010. The surgical instrument can have a variety of configurations.For example, in this illustrated embodiment, the surgical instrument2102 includes an outer sleeve 2103 and first and second channel arms2106, 2108. While two channel arms 2106, 2108 are illustrated, in otherembodiments, the surgical instrument can include a single channel arm ormore than two channel arms. The outer sleeve 2103 is configured to beinserted through a patient's mouth (not shown) and down the trachea2014. The outer sleeve 2103 includes a working channel 2104 that isconfigured to allow the first and second channel arms 2106, 2108 to beinserted through the outer sleeve 2103 and access the lung 2010. Assuch, the first and second channel arms 2106, 2108 can be configured tomove independently of the working channel 2014.

Each of the first and second channel arms 2106, 2108 can include atleast one anchor member coupled to the at least one channel arm andconfigured to move between expanded and unexpanded states. When in theexpanded state, the at least one anchor member is configured to be atleast partially disposed within a second natural body lumen, the secondnatural body lumen being in communication with a first natural bodylumen that the outer sleeve is partially disposed within. In thisillustrated embodiment, a first anchor member 2113 (see FIG. 23A, FIG.23B, and FIG. 24 ) is coupled to first channel arm 2106 and a secondanchor member 2115 (see FIG. 26 ) is coupled to the second channel arm2108 Further, as shown in FIG. 22 and FIG. 23, the first natural bodylumen is the right bronchus 2016 and the second natural body lumen isthe first bronchiole 2022.

Further, each of the first and second channel arms 2106, 2108 alsoinclude control actuators and a fluid tube which extend along the lengthof the channel arms and further extends from the proximal end 2103 p ofthe outer sleeve 2103. As shown in FIG. 22 , the first channel arm 2106includes three control actuators 2106 a, 2106 b, 2106 c and a firstfluid tube 2107. The second channel arm 2108 includes three controlactuators 2108 a, 2108 b, 2108 c and a second fluid tube 2109. Asdescribed in more detail below, the control actuators of each controlarm are configured to allow for manipulation of the lung 2010, and thefluid tubes 2107, 2109 are configured to provide a fluid to the firstand second anchor members 2113, 2115 coupled to the first and secondchannel arms 2106, 2108.

In use, as shown in FIG. 22 , the outer sleeve 2103 is passed into thetrachea 2014 through a patient's mouth (not shown). With the outersleeve in position, the anchor member 2105 moves to an expanded state,where the anchor member 2105 at least partially contacts an internalsurface 2017 of the right bronchus 2016. By contacting the inner surface2017, the outer sleeve 2103 is fixated to the trachea 2014 and the rightbronchus 2016. The first channel arm 2106 is passed into the lung 2010through the right bronchus 2016 via the outer sleeve 2105, and into thefirst bronchiole 2022 of the upper lobe 2020, and the second channel arm2108 is passed into the lung 2010 through the right bronchus 2016, andinto the second bronchiole 2024 of the middle lobe 2023. Once the firstand second channel arms 2106, 2108 are properly positioned within thefirst and second bronchi 2022, 2024, respectively, the first and secondanchor member 2113, 2115 can be expanded to at least partially contactthe inner surface of the bronchioles 2022, 2024. For sake of simplicity,the following description is with respect to the first anchor member2113. A person skilled in the art will understand, however, that thefollowing discussion is also appliactuator to the second anchor member2115, which as shown in FIG. 26 is structurally similar to that of thefirst anchor member 2113. A detailed partial view of the first anchormember 2113 is illustrated in an unexpanded state (FIG. 23A) and in anexpanded state (FIG. 23B).

As shown, the first anchor member 2113 is arranged distal to the distalend 2103 d of the outer sleeve 2103 such that the first anchor member2113 can be positioned within the first bronchiole 2022. The firstanchor member 2113 is configured to move between an unexpanded state(FIG. 23A) and an expanded state (FIG. 23B). The first anchor member2113 can have a variety of configurations. For example, in someembodiments, the first anchor member can be an inflatable balloon,whereas in other embodiments, the first anchor member can be amechanically expandable stent.

As illustrated in FIG. 23A and FIG. 23B, the first anchor member 2113includes three bladders 2113 a, 2113 b, 2113 c arranged about an outersurface of the first fluid tube 2107. The bladders 2113 a, 2113 b, 2113c are separated from one another (e.g., by control actuators 2106 a,2106 b, and 2106 c arranged between the bladders 2113 a, 2113 b, 2113c). The bladders 2113 a, 2113 b, 2113 c are expanded by the ingress offluid through the first fluid tube 2107, which is in fluid communicationwith each bladder 2113 a, 2113 b, 2113 c, and unexpanded through theegress of fluid from the bladders 2113 a, 2113 b, 2113 c through thefirst fluid tube 2107. In some embodiments, each bladder 2113 a, 2113 b,2113 c extends along the length of the first channel arm 2106.Alternatively, in certain embodiments, the bladders 2113 a, 2113 b, 2113c are arranged along only a portion of the length of the first channelarm 2106.

Alternatively, or in addition, at least one of the first and secondchannel arms 2106, 2108 can include an optical sensor. By way ofexample, FIG. 25 illustrates a partial view of a distal end 2106 d ofthe first channel arm 2106. As shown, the distal end 2106 d of thechannel arm 2106 can include a scope 2114 with an optical sensor 2110arranged thereon. The optical sensor 2110 can be configured to allow auser to determine the location of the first channel arm 2106 within thelung 2010 and to help the user position the distal tip 2106 d into thedesired bronchiole, such as first bronchiole 2022. Views from theoptical sensor 2110 can be provided in real time to a user (e.g., asurgeon), such as on a display (e.g., a monitor, a computer tabletscreen, etc.). The scope 2114 can also include a light 2111 and aworking channel and/or a fluid channel 2112 that is configured to allowfor the insertion and extraction of a surgical instrument and/or for theingress and egress of a surgical instrument or fluid to the treatmentsite within the lung 2010. A person skilled in the art will appreciatethat the second channel arm can alternatively or in addition include ascope that is similar to scope 2114 in FIG. 25 .

In some embodiments, the outer sleeve 2103 can include additionalelements. For example, as shown in FIG. 22 , and in more detail in FIG.25 , the outer sleeve 2103 includes an anchor member 2105 arrangedproximate to a distal end 2103 d of the outer sleeve 2103. In otherembodiments, the anchor member 2105 can be arranged at the distal end2103 d.

A detailed partial view of the distal end 2130 d of the outer sleeve2103 and the channel arms 2106, 2108 is illustrated in FIG. 25 . Asshown, the channel arms 2106, 2108 extend outward from the distal end2103 d of the outer sleeve 2103. In some embodiments, the channel arms2106, 2108 can move relative to each other, and the outer sleeve 2103.As stated above, an anchor member 2105 is arranged on the outer sleeve2103. The anchor member 2105 is configured to move between expanded andunexpanded states. In an expanded state, the anchor member 2105 isconfigured to at least partially contact an internal surface 2017 of theright bronchus 2016. By contacting the inner surface 2017, the outersleeve 2103 can be fixated to the trachea 2014 and the right bronchus2016. This fixation can allow for a manipulation force (e.g., twistingforce) to be applied to the lung 2010 through the channel arms 2106,2108. As a result, the lung 2010 can be mobilized relative to thetrachea 2014 and the right bronchus 2016.

Increasing of the distribution of forces applied to the lung 2010 andreducing the tissue interaction pressure can be achieved by increasingthe internal surface area in which the anchor members interact with. Theanchor elements are configured to expand to the internal diameter of thebronchus. By spreading to the full internal diameter, and having thechannel arms extended from the distal end of the outer sleeve, thesurgical anchoring system acts as a skeleton system within the lung. Bymoving the outer sleeve and/or channel arms, the bronchioles or bronchusare moved, thereby moving the lung. Since the outer sleeve and anchoringelements are spread out over a large area, the forces applied to thelung are not concentrated, compared to manipulating the lung with smallgraspers from the laparoscopic side. Additionally the cartridge ringsand wall strength of the bronchus make it more ideal for instrumentinteraction for gross lung movement or repositioning without collateraldamage to the surrounding softer and more fragile pleura and parenchyma.

In an example embodiment, bifurcating and extending a portion of thesurgical anchor system down two separate distal branches from the outersleeve 2103 can be used to better hold a larger, more triangulated areaof the lung 2010. Additionally, a portion of the outer sleeve 2103 canexpand in addition to the channel arms 2106, 2108 extending from theworking channel. Additionally the outer sleeve 2103 can include radialexpandable elements that would provide additional contact area withinthe trachea 2014 that would allow the surgical anchoring system 2100 tocompletely control both the flexion, but also twist, expansion, and/orcompression of the lung 2010. This would enable the surgical anchoringsystem 2100 to guide the lung to the correct location and positionwithin the thoracic cavity, but also to control the shape of the lung sothat a dissection and/or transection could be done from the thoraciccavity side.

The anchor member 2105 can have a variety of configurations. Forexample, in some embodiments, the anchor member 2105 can be aninflatable anchoring balloon. In embodiments where the anchor member2105 is an inflatable anchoring balloon, the anchor member 2105 isconfigured to expand or collapse through the ingress or egress of afluid passing through a fluid tube (not shown) in fluid communicationwith the anchor member 2105. The fluid tube extends along the length ofthe outer sleeve 2103 and can be controlled outside of a patient's body.In other embodiments, the anchor member 2105 can be a mechanicallyexpandable stent.

With the channel arms 2106, 2108 properly arranged within thebronchioles 2022, 2024, the lung 2010 is collapsed. This results in thelung considerably shrinking in size relative to its size in its inflatedstate. The lung 2010 as illustrated in FIG. 26 is in a collapsed state,with the previous inflated state being represented as a dashed-lineborder IS. In use, when in the expanded state as shown in FIG. 26 , thefirst anchor member 2113 is configured to at least partially contact theinternal surface 2022 a of the first bronchiole 2022. This contactfixates the first anchor member 2113 to the first bronchiole 2022, andthereby the lung 2010. The first anchor member 2113 can alternatebetween its unexpanded and expanded states by passing fluid into orremoving fluid from the bladders 2113 a, 2113 b, 2113 c through thefluid tube 2107 that passes through the length of the channel arm 2106.The fluid passed into or out of the bladders 2113 a, 2113 b, 2113 c canbe any suitable fluid (e.g., saline, carbon dioxide gas, and the like).A proximal-most end (not shown) of the fluid tube 2107 is configured tocouple to fluid system that can be used to control the ingress or egressof fluid into the bladders 2113 a, 2113 b, 2113 c. The fluid system caninclude a pump and a fluid reservoir. The pump creates a pressure whichpushes the fluid into the bladders 2113 a, 2113 b, 2113 c, to expand thebladders 2113 a, 2113 b, 2113 c, and creates a suction that draws thefluid from the bladders 2113 a, 2113 b, 2113 c in order to collapse thebladders 2113 a, 2113 b, 2113 c. A person skilled in the art willappreciate that the second anchor member 2115 can be moved between anexpanded and unexpanded state within the second bronchiole 2024 in asimilar way as discussed above with respect to the first anchor member2113.

Further, in use other surgical instruments 2120, 2122 can be introducedlaparoscopically within the thoracic cavity in order to visualize and/oroperate on the lung 2010 from the extraluminal space. The surgicalinstruments 2120, 2122 can include a variety of surgical tools, such asgraspers 2123, optical sensors 2124, and/or electrosurgical tool 2125.In an exemplary embodiment, where the surgical instrument 2122 is orincludes an optical sensor 2124, a user (e.g., a surgeon) can visuallyinspect the collapsed lung 2010 (FIG. 26 ) to perform an incision on thelung 2010 using the graspers 2123 or the electrosurgical tool 2125.

Moreover, in use, with the anchor members 2113, 2115 in expanded states,manipulation forces can be applied to the lung 2010 through the controlactuators 2106 a, 2106 b, 2106 c, 2108 a, 2108 b, 2108 c. In someembodiments, the surgical anchoring system 2100 includes a controller2050 that is configured to coordinate a motion of the channel arms 2106,2108 within the bronchioles 2022, 2024 and a motion of at least oneinstrument 2120, 2122 outside of the lung 2010 to prevent tearing of thebronchioles 2022, 2024 or the exterior tissue surface 2012 of the lung2010. The controller 2050 can be communicatively coupled to the roboticarms (not shown) which the instruments 2120, 2122 are connected to, andto actuators 2052, 2054. The actuator 2052 is configured to apply themanipulation forces F₁, F₂, F₃ to control actuators 2106 a, 2106 b, 2106c, and the actuator 2054 is configured to apply the manipulation forcesF₄, F₅, F₆ to control actuators 2108 a, 2108 b, 2108 c.

In use, manipulation force F₁ is applied to control actuator 2106 a,manipulation force F₂ is applied to control actuator 2106 b,manipulation force F₃ is applied to control actuator 2106 c,manipulation force F₄ is applied to control actuator 2108 a,manipulation force F₅ is applied to control actuator 2108 b, andmanipulation force F₆ is applied to control actuator 2108 c. With themanipulation forces applied to the lung 2010, the horizontal fissurebetween the upper lobe 2020 and the middle lobe 2023 can be widened toform a gap G. The gap G allows for access to the lung 2010 so thehorizontal fissure can be further expanded. The manipulation forcescause the channel arms 2106, 2108 to move in opposite directions,causing the upper lobe 2020 to move away from the middle lobe 2023. Theanchor member 2115, in an expanded state within the right bronchus 2016,prevents unintended twisting of the lung 2010 while the manipulationforces are applied to the lung 2010. As such, the lung 2010 can bemanipulated in a single plane in order to increase the gap G in anefficient manner. With the manipulation complete, the anchor members2113, 2115 are deflated and removed from the bronchioles 2022, 2024 andout through the outer sleeve 2103. The anchor member 2105 is alsodeflated, allowing the outer sleeve 2103 to also be removed from thetrachea 2014, causing little to no damage to the trachea 2014 or lung2020 when compared to conventional procedures using graspers only tomobilize the lung 2020.

If a surgeon has at least one channel arm 2106, 2108 deployed within abronchiole, and the grasper 2123 arranged on the laparoscopic side ofthe lung 2010, both the channel arm and the instrument could be driventogether to move in the same direction or in opposed directions. Movingboth in the same direction would allow for supported movement of thesection grasped between them. Moving both in opposite directions wouldcreate tissue tension which would make it easier for dissection ortissue plane separation. Moving both in the same direction could also becoordinated in a coupled motion or an antagonistic manner where eitherthe channel arm or instrument was the driver coupling, and the otherwould be the follower while providing a defined sustainable forcebetween the channel arm and instrument. In some embodiments, other formsof synchronized motion can include a maximum threshold for coupledforces, position control, and/or velocity matching.

FIG. 27 illustrates a schematic view of a surgical anchoring system 2200arranged within a collapsed lung 2201. Aside from the differencesdescribed in detail below, the surgical anchoring system 2200 and thecollapsed lung 2201 can be similar to the surgical anchoring system 2100in FIG. 22 and FIG. 26 and the collapsed lung 2010 in FIG. 26 andtherefore common features are not described in detail herein.

The surgical anchoring system 2200 includes a surgical instrument 2202,an outer sleeve 2203, an anchor member 2205 coupled to the outer sleeve2203, a first channel arm 2206, and a second channel arm 2208. The firstchannel arm 2206 includes control actuators 2206 a, 2206 b, 2206 cextending along the length of the channel arm 2206 and configured toprovide a manipulation force to the lung 2201 (e.g., through the firstbronchiole 2022). The second channel arm 2208 includes control actuators2208 a, 2208 b, 2208 c extending along the length of the second channelarm 2208 and configured to provide a manipulation force to the lung 2201(e.g., through the second bronchiole 2024).

As shown in FIG. 27 , the first channel arm 2206 includes anchor members2213 a, 2213 b, 2213 c, 2213 d, 2213 e that are arranged on a clutchactuator 2207 that extends through the first channel arm 2206. Each ofthe anchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213 e are configuredto move axially along the length of the channel arm 2206. The clutchactuator 2207 is configured to selectively position the anchor members2213 a, 2213 b, 2213 c, 2213 d, 2213 e at an axial position along thelength of the first channel arm 2206. Similar to the anchor member 2113,the anchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213 e each includeinflatable bladders which can be mechanically expanded or filled with afluid through a fluid channel extending through the length of the clutchactuator 2207.

Additionally, second channel arm 2208 includes anchor members 2215 a,2215 b, 2215 c, 2215 d, 2215 e arranged on a clutch actuator 2209. Eachof the anchor members 2215 a, 2215 b, 2215 c, 2215 d, 2215 e areconfigured to move axially along the length of the second channel arm2208. The clutch actuator 2209 is configured to selectively position theanchor members 2215 a, 2215 b, 2215 c, 2215 d, 2215 e at an axialposition along the length of the second channel arm 2208. Similar to theanchor member 2115, the anchor members 2215 a, 2215 b, 2215 c, 2215 d,2215 e each include inflatable bladders which can be mechanicallyexpanded or filled with a fluid through a fluid channel extendingthrough the length of the clutch actuator 2209.

In use, the outer sleeve 2203 is inserted and the anchor member 2205 ismoved to an expanded state to contact the inner tissue surface 2022 a ofthe right bronchus 2016. The first and second channel arms 2206, 2208are inserted into and arranged within the bronchioles 2022, 2024 priorto the lung 2010 being collapsed. After the lung 2010 is collapsed, theanchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, 2215 a, 2215 b,2215 c, 2215 d, 2215 e are moved to an expanded state to contact aninner tissue surface 2022 a of the bronchioles 2022, 2024.

With the anchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, 2215 a,2215 b, 2215 c, 2215 d, 2215 e in an expanded state, the clutchactuators 2207, 2209 can be axially displaced relative to the outersleeve 2103, pushing the clutch actuators 2207, 2209 further into thefirst and second bronchioles 2022, 2024. In some embodiments, the anchormembers 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, 2215 a, 2215 b, 2215 c,2215 d, 2215 e can slide relatively along the clutch actuators 2207,2209 a prescribed amount before being coupled to the clutch actuators2207, 2209. This allows for a space to form between each of the anchormembers 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, 2215 a, 2215 b, 2215 c,2215 d, 2215 e, which pulls the loose tissue surrounding the first andsecond bronchioles 2022, 2024 taut. As the clutch actuators 2207, 2209are retracted from the lung 2201, the gap between each of the anchormembers 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, 2215 a, 2215 b, 2215 c,2215 d, 2215 e is reduced, collapsing the tissue surrounding the firstand second bronchioles 2022, 2024.

In addition to manipulating the lung 2201 using the control actuators ofthe first channel arms 2206, the first clutch actuator 2207 can be usedto axially move the anchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213e along a length of the first channel arm 2206. By axially moving theanchor members 2213 a, 2213 b, 2213 c, 2213 d, 2213 e, the upper lobe2020 and first bronchiole 2022 are partially expanded to an inflatedstate through the mechanical expansion of the anchor members 2213 a,2213 b, 2213 c, 2213 d, 2213 e. As illustrated, the exterior tissuesurface 2021 of the upper lobe 2020 at the horizontal fissure is tautdue to the axially expansion of the anchor members 2213 a, 2213 b, 2213c, 2213 d, 2213 e when compared to the exterior tissue surface 2025 ofthe middle lobe 2023, which is bunched up due to the collapsed state ofthe lung 2010. The axial expansion of the anchor members 2213 a, 2213 b,2213 c, 2213 d, 2213 e also places the upper lobe 2020 in a similarshape to when the lung 2201 is inflated, as shown by the inflated stateline IS.

Similarly, in addition to manipulating the lung 2201 using the controlactuators of the second channel arm 2208, the second clutch actuator2209 can be used to axially move the anchor members 2215 a, 2215 b, 2215c, 2215 d, 2215 e along a length of the second channel arm 2208. Byaxially moving the anchor members 2215 a, 2215 b, 2215 c, 2215 d, 2215e, the middle lobe 2023 and second bronchiole 2024 can partiallyexpanded, similar the upper lobe 2020. The axial expansion of the anchormembers 2215 a, 2215 b, 2215 c, 2215 d, 2215 e also can place the middlelobe 2023 in a similar shape to when the lung 2201 is inflated, as shownby the inflated state line IS.

In other embodiments, the amount of axial extension by the anchormembers can be guided by a user, but have force limits corresponding tothe amount of force capable of being exerted between two anchor members.Additionally, there can be a maximum limit on the amount of displacementbetween two anchor members to prevent over distention of the organ. Incertain embodiments, the anchor members themselves can also have loadlimits by either controlling the maximum expansive force for limitingfriction. The anchor members can have integrated sensors that wouldlimit the externally applied forces between the anchor members as theyare axially displaced. The force applied radially could beproportionately coupled to the longitudinal forces applied to preventinadvertent diametric stretch damage even when applying only a smalldelicate stretching motion. Alternatively or in addition, the surgicalanchoring system can be run in a form of load/creep control, allowingfor the maintaining of a predefined force, and then automaticallycontinuing to extend proportionate to the creep in the tissue of theorgan. This would allow the viscoelastic properties of the tissue of theorgan to be used to help the expansion of the organ rather than hinderthe expansion.

In certain embodiments, prior to the activation of the axial movement ofthe anchor members, a structured light scan can be taken of the tissue,providing a 3D surface model of the pre-stretched anatomy of the organ.This image can be stored and overlaid to the stretch condition of theorgan, providing visual information on the nature of the organ shapechange, providing insights to the unseen branching of the organ belowthe exterior tissue surface.

As noted above, the present surgical anchoring systems can be configuredto manipulate other natural body lumens or organs. For example, asdiscussed below, the present surgical anchoring systems can beconfigured to manipulate one or more portions of the colonendoscopically.

Surgery is often the primary treatment for early-stage colon cancers.The type of surgery used depends on the stage (extent) of the cancer,its location in the colon, and the goal of the surgery. Some early coloncancers (stage 0 and some early stage I tumors) and most polyps can beremoved during a colonoscopy. However, if the cancer has progressed, alocal excision or colectomy, a surgical procedure that removes all orpart of the colon, may be required. In certain instances, nearby lymphnodes are also removed. A hemicolectomy, or partial colectomy, can beperformed if only part of the colon is removed. In a segmental resectionof the colon the surgeon removes the diseased part of the colon alongwith a small segment of non-diseased colon on either side. Usually,about one-fourth to one-third of the colon is removed, depending on thesize and location of the cancer. Major resections of the colon areillustrated in FIG. 28 , in which (i) A-B is a right hemicolectomy, A-Cis an extended right hemicolectomy, B-C is a transverse colectomy, C-Eis a left hemicolectomy, D-E is a sigmoid colectomy, D-F is an anteriorresection, D-G is a (ultra) low anterior resection, D-H is anabdomino-perineal resection, A-D is a subtotal colectomy, A-E is a totalcolectomy, and A-H is a total procto-colectomy. Once the resection iscomplete, the remaining intact sections of colon are then reattached.

During a laparoscopic-assisted colectomy procedure, it is oftendifficult to obtain an adequate operative field. Often times,dissections are made deep in the pelvis which makes it difficult toobtain adequate visualization of the area. As a result, the lower rectummust be lifted and rotated to gain access to the veins and arteriesaround both sides of the rectum during mobilization. During manipulationof the lower rectum, bunching of tissue and/or overstretching of tissuecan occur. Additionally, a tumor within the rectum can cause adhesionsin the surrounding pelvis, and as a result, this can require freeing therectal stump and mobilizing the mesentery and blood supply beforetransection and removal of the tumor.

Further, as illustrated in FIG. 29 , multiple graspers 2300, 2302, 2304,2306 and a laparoscope 2301 are needed to position a tumor 2308 forremoval from the colon 2310. During dissection of the colon 2310, thetumor 2308 should be placed under tension, which requires grasping andstretching the surrounding healthy tissue 2312, 2314, 2316 of the colon2310. However, the manipulating of the tissue 2312, 2314, 2316surrounding the tumor 2308 can suffer from reduced blood flow and traumadue to the graspers 2300, 2302, 2304, 2306 placing a high grip force onthe tissue 2312, 2314, 2316. Additionally, during a colectomy, thetransverse colon and upper descending colon may need to be mobilizedallowing the good remaining colon to be brought down to connect to therectum 2318 after the section of the colon 2310 containing the tumor2308 is transected and removed. A surgical tool that can be used tosafely manipulate the colon to provide the surgeon with bettervisualization and access to the arteries and veins during mobilizationwould help prevent trauma and blood loss to the surrounding area duringa colectomy.

FIG. 30 and FIG. 31 illustrate one embodiment of a surgical anchoringsystem 2400 that is configured for endoluminal access into andmanipulation of a colon 2310. As will be described in more detail below,the surgical anchoring system 2400 is used to manipulate and tension aportion of the colon 2310 (e.g., section F). For purposes of simplicity,certain components of the surgical anchoring system 2400 and the colon2310 are not illustrated. While this surgical anchoring system 2400 isshown and described in connection with manipulation of section F of thecolon 2310, a person skilled in the art will appreciate that thesurgical anchoring system 2400 can be used to additionally, or in thealternative, inflate other sections of the colon 2310.

As illustrated in FIG. 30 and FIG. 31 , the surgical anchoring system2400 can have a variety of configurations. In some embodiments, thesurgical anchoring system 2400 includes a tubular member 2402 configuredfor endoluminal access through a natural orifice, such as the rectum2318 and into the colon 2310. The tubular member 2402 includes a centrallumen 2404 arranged therein and configured to receive an endoscope.Additionally, the tubular member 2402 includes a plurality of workingchannels formed from working channels 2406 a, 2406 b, 2406 c, 2408 a,2408 b, 2408 c, 2410 a, 2410 b, 2410 c extending therethrough. In otherembodiments, the tubular member can have other suitable configurationsand shapes.

The surgical anchoring system 2400 also includes an anchoring assembly2418 coupled to the tubular member 2402 and extending distally from thedistal end 2402 d of the tubular member 2402. The anchoring assembly2418 includes a first anchor member 2420 and a second anchor member2430. The first anchor member 2420 is coupled to the distal end 2402 dof the tubular member 2402 and is configured to engage a firstanatomical location and secure the first anatomical location relative tothe tubular member 2402 (FIG. 32 ). The first anchor member 2420includes a first plurality of expandable anchoring elements 2422extending between a proximal collar 2424 and a distal collar 2426. Thedistal collar 2426 is configured to axially move relative to theproximal collar 2424, such that when the distal collar 2426 movesaxially towards the proximal collar 2424, the expandable anchoringelements 2422 expand radially outward from the axis of axial movement bythe distal collar 2426. By expanding radially outward, the expandableanchoring elements 2422 are configured to at least partially contact aninner tissue surface of a natural body lumen or organ while in anexpanded state.

In order to axially displace the distal collar 2426 towards the proximalcollar 2424, a first plurality of actuators 2412 is connected to thedistal collar 2426. The first plurality of actuators 2412 includesactuators 2412 a, 2412 b, 2412 c, where actuator 2412 a passes throughthe working channel 2406 a, actuator 2412 b passes through the workingchannel 2406 b, and the actuator 2412 c passes through the workingchannel 2406 c. As the actuators 2412 a, 2412 b, 2412 c are tensionedand pulled through or rotated within the working channels, the distalcollar 2426 is axially displaced towards the proximal collar 2424,expanding the expandable anchoring elements 2422. In order for theactuators 2412 a, 2412 b, 2412 c to interact with the distal collar2426, the actuators 2412 a, 2412 b, 2412 c pass through a plurality ofworking channels (not shown) within the proximal collar 2424.

The second anchor member 2430 is moveable relative to the first anchormember 2420 and positioned distal to the first anchor member 2420 at adistance D₁. The second anchor member 2430 is configured to engage asecond anatomical location and is moveable relative to the firstanatomical location (FIG. 32 ). The second anchor member 2430 includes asecond plurality of expandable anchoring elements 2432 extending betweena proximal collar 2434 and a distal collar 2436. The distal collar 2436is configured to axially move relative to the proximal collar 2434, suchthat when the distal collar 2436 moves axially towards the proximalcollar 2434, the expandable anchoring elements 2432 expand radiallyoutward from the axis of axial movement by the distal collar 2436. Byexpanding radially outward, the expandable anchoring elements 3432 areconfigured to at least partially contact an inner tissue surface of anatural body lumen or organ while in an expanded state.

In order to axially displace the distal collar 2436 towards the proximalcollar 2434, a second plurality of actuators 2414 is connected to thedistal collar 2436. The second plurality of actuators 2414 includesactuators 2414 a, 2414 b, 2414 c, where actuator 2414 a passes throughthe working channel 2408 a, actuator 2414 b passes through the workingchannel 2408 b, and the actuator 2414 c passes through the workingchannel 2408 c. As the actuators 2414 a, 2414 b, 2414 c are tensionedand pulled through or rotated within the working channels, the distalcollar 2436 is axially displaced towards the proximal collar 2434,expanding the expandable anchoring elements 2432. In order for theactuators 2414 a, 2414 b, 2414 c to interact with the distal collar2436, the actuators 2414 a, 2414 b, 2414 c pass through working channels2438 within the proximal collar 2434, and a plurality of workingchannels (not shown) within the proximal collar 2424 and the distalcollar 2426 of the first anchoring element 2420.

As illustrated in FIG. 31 and FIG. 32 , with the first anchor member2424 and the second anchor member 2434 in expanded states, the firstanchor member 2424 is engaged with the first anatomical location 2320,and the second anchor member is engaged with the second anatomicallocation 2322. In order to axially displace the second anchor member2430 relative to the first anchor member 2420, the actuators 2416 a,2416 b, 2416 c are rotated in order to unscrew the actuators 2416 a,2416 b, 2416 c from the threaded sheaths 2417 a, 2417 b, 2417 c. Theactuator 2416 a is threaded within the threaded sheath 2417 a, theactuator 2416 b is threaded within the threaded sheath 2417 b, andactuator 2416 c is threaded within the threaded sheath 2417 c. Since theactuators and threaded sheaths have complementary threads, the rotationof the actuators 2416 a, 2416 b, 2416 c causes the distance between thefirst anchor member 2420 and the second anchor member 2430 to increase.In some embodiments, once of the actuators 2416 a, 2416 b, 2416 c can berotated more than the other actuators, causes a curved length D₂, whichis greater than D₁, between the first anchor member 2420 and the secondanchor member 2430.

In use, the curved length D₂ can be used to create tension on one sideof the colon 2310, such as where the location of a tumor is located.Since the first anatomical location 2320 is engaged with the firstanchor member 2420 by the expandable anchoring elements 2422, and thesecond anatomical location 232 is engaged with the second anchor member2430 by the expandable anchoring elements 2432, when the actuators 2416a, 2416 b, 2416 c are rotated and unthreaded, the second anatomicallocation 2322 is selectively repositioned relative to the firstanatomical position 2320.

As illustrated in FIG. 32 , the tissue wall 2324 is tensioned at agreater degree than the tissue wall 2326, arranged opposite the tissuewall 2324. By tensioning the tissue wall 2324, where the tumor 2308 islocated on the colon 2310, the tumor can be visualized and removed bylaparoscopically arranged instruments 2332, 2334. Additionally, tofurther help visualize the tumor 2308, an endoscope 2330 is arrangedwithin the central lumen 2404 of the tubular member 2402.

Sensing Surgical Instruments

During certain surgical procedures, it may be advantageous to be able totrack the location and orientation of certain surgical instrumentswithin a patient's body. For example, during a colon resection, themobilized portion of the colon must be aligned and connected to therectum in order to reattach the colon to the rectum. In certain surgicalsystems, at least one of the surgical instruments can include integratedtracking and coordinating means that identifies a location of thesurgical instruments relative to each other.

In some embodiments, a surgical instrument can include one or moremarkers (e.g., attachable or integrated markers) that can be used totrack the surgical instrument. This can allow the surgical instrument todirectly cooperate with the dual sensing and cooperative controlsystems. As a result, the surgical instrument can be directly insertedinto the body (e.g., into a natural orifice) without a scope (e.g., anendoscope) and used similarly to a scope for.

FIG. 33 illustrates another embodiment of a surgical anchoring system2500. The surgical anchoring system 2500 includes attachable orintegrated markers and a sensing means for use with an instrumentintroduced through a natural orifice without another scope that wouldenable it to cooperate with the dual sensing and cooperative controlsystems.

The surgical anchoring system 2500 includes a laparoscopically arrangedinstrument 2502 having a sensing array 2504. The sensing array 2504 isconfigured to interact wirelessly with a first collar 2506 and a secondcollar 2508 in order to align a circular stapler 2510 arranged withinthe rectum 2318 with the anvil 2512 arranged within the remainder of thecolon 2310. The first collar 2506 is arranged within the circularstapler 2510 and emits a magnetic field 2514. The second collar 2508 isarranged on the anvil 2512 and emits a magnetic field 2516. Both themagnetic fields 2514, 2516 are detectable by the sensing array 2504. Themagnetic fields 2514, 2516 are configured to relay location andorientation data about the circular stapler 2510 and the anvil 2512 inorder to align the colon 2310 with the rectum 2318.

The anvil 2512 include a post 2518, which is grasped by an instrument2520 in order to mobilize the colon 2310. As the anvil 2512 is moved bythe instrument 2520, the sensing array 2504 collects magnetic field dataand determines the distance and misalignment of the stapler trocar axis2522 and the anvil trocar axis 2524. When the stapler trocar axis 2522is aligned with the anvil trocar axis 2524, the anvil 2512 can bepositioned over the post 2526 of the circular stapler 2510. The post2526 can include alignment features 2528 as the post 2518 is arrangedover the post 2526. In certain embodiments, the circular stapler 2510can be rotated once the posts 2518, 2526 are aligned with each other,coupling the anvil 2512 to the circular stapler 2510 so that the colon2310 can be stapled to the rectum 2318.

The instrument 2502 can include an optical sensor arranged on the distalend thereof in order to visualize the treatment area to an externalscreen in view of a user, aiding them in adjusting and aligning thecircular stapler to the correct location for anvil attachment from thelaparoscopic side.

The surgical anchoring system disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. In either case, however, the surgical anchoring systemcan be reconditioned for reuse after at least one use. Reconditioningcan include any combination of the steps of disassembly of the surgicalanchoring system, followed by cleaning or replacement of particularpieces and subsequent reassembly. In particular, the surgical anchoringsystem can be disassembled, and any number of the particular pieces orparts of the surgical anchoring system can be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, the surgical anchoring system can be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a surgical anchoring system canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditionedinstrument, are all within the scope of the present application.

Instrument Control Imaging Systems

Devices, systems, and methods for multi-source imaging provided hereinallow for cooperative surgical visualization. In general, in cooperativesurgical visualization, first and second imaging systems (e.g., firstand second scope devices) each gathering images of a surgical site areconfigured to cooperate to provide enhanced imaging of a surgical site.The cooperative surgical visualization may improve visualization ofpatient anatomy at the surgical site and/or improve control of surgicalinstrument(s) at the surgical site.

A surgical visualization system can allow for intraoperativeidentification of critical structure(s) (e.g., diseased tissue,anatomical structures, surgical instrument(s), etc.). The surgicalvisualization system may thus enable enhanced intraoperative decisionmaking and improved surgical outcomes. The surgical visualization systemcan provide advanced visualization capabilities beyond what a medicalpractitioner sees with the “naked eye” and/or beyond what an imagingsystem can recognize and/or convey to the medical practitioner. Thesurgical visualization system can augment and enhance what a medicalpractitioner is able to know prior to tissue treatment (e.g.,dissection, etc.) and, thus, may improve outcomes in various instances.As a result, the medical practitioner can confidently maintain momentumthroughout the surgical procedure knowing that the surgicalvisualization system is tracking a critical structure, which may beapproached during dissection, for example. The surgical visualizationsystem can provide an indication to the medical practitioner insufficient time for the medical practitioner to pause and/or slow downthe surgical procedure and evaluate the proximity to the criticalstructure to prevent inadvertent damage thereto. The surgicalvisualization system can provide an ideal, optimized, and/orcustomizable amount of information to the medical practitioner to allowthe medical practitioner to move confidently and/or quickly throughtissue while avoiding inadvertent damage to healthy tissue and/orcritical structure(s) and, thus, to minimize the risk of harm resultingfrom the surgical procedure.

The surgical systems provided herein generally include a first scopedevice configured to transmit image data of a first scene within itsfield of view, a second scope device configured to transmit image dataof a second, different scene within its field of view, a tracking deviceassociated with one of the first scope device or the second scope deviceand configured to transmit a signal indicative of a location of the oneof the first scope device or the second scope device relative to theother one of the first scope device or the second scope device, acontroller configured to receive the transmitted data and signal,determine the relative distance between the first and second scopedevices and provide a merged image. The merged image can be at least aportion of at least the first scope device and the second scope devicein a single scene, and at least one of the first scope device and thesecond scope device in the merged image is a representative depictionthereof. Thus, the merged image may thus provide two separate points ofview of the surgical site, which can conveniently allow a medicalpractitioner to view only one display instead of multiple displays.Further, within that one display, the merged image allows a medicalpractitioner to coordinate relative location and/or orientation of atleast the first and scope devices arranged at or proximate to thesurgical site.

The first scope device is configured to be at least partially disposedwithin at least one of a natural body lumen and an organ (e.g., a lung,a stomach, a colon, or small intestines), and the second scope device isconfigured to be at least partially disposed outside of the at least oneof the natural body lumen and the organ. In certain embodiments, thefirst scope device is endoscope and the second scope device is alaparoscope. The natural body lumen or organ can be any suitable naturalbody lumen or organ. Non-limiting examples include a stomach, a lung, acolon, or small intestines.

The surgical systems provided herein can also be used in various roboticsurgical systems, such as those discussed above, and can incorporatevarious tracking and/or imaging mechanisms, such as electromagnetic (EM)tracked tips, fiber bragg grating, virtual tags, fiducial markers, useof probes, identification of known anatomy, various 3D scanningtechniques such as using structured light, various sensors and/orimaging systems discussed previously, etc., to assist in trackingmovement of the instruments, endoscopes, and laparoscopes relative toeach other and/or the overall system. The tracking mechanisms can beconfigured to transmit tracking data from both a laparoscope and anendoscope so that the location of either scope can be determinedrelative to the other scope. Additionally, critical structures withinthe field of view of either scope (e.g., diseased tissue, surgicalinstruments, anatomical structures) can be tracked by the scope whichhas such critical structures within their field of view. In total, thesurgical systems herein can track the objects within a field of view ofeach scope, and the relative position of each scope. Therefore, thetotality of the tracking data allows the system to calculate thedistance of a critical structure from a scope which does not have acritical structure in its field of view based on the tracking datacollected by the other scope.

In some embodiments, the surgical system can include a tracking deviceassociated with one of the first scope device or the second scope deviceand configured to transmit a signal indicative of a location of the oneof the first scope device or the second scope device relative to theother one of the first scope device or the second scope device.

In various embodiments, the surgical systems provided herein includes acontroller. The surgical system, the controller, a display, and/or thevarious instruments, endoscopes, and laparoscopes can also beincorporated into a number of different robotic surgical systems and/orcan be part of a surgical hub, such as any of the systems and surgicalhubs discussed above. The controller in general is configured to mergefirst and second scenes from an endoscope and a laparoscope,respectively, to visually create a merged image between the first andsecond scenes. The controller is configured to receive the tracking datadetailed above, and in combination with the first and second scenes,generate the merged image containing a representative depiction of atleast the endoscope or laparoscope, and any structures within field ofview of the scope which is visually impaired by a tissue wall. Forexample, if the merged image was from a point-of-view of the endoscope,the merged image is the live image stream of what the endoscope isviewing, while including an overlay of the orientations and locations oflaparoscopically arranged surgical instruments and a laparoscope, ifpresent.

In some embodiments, the controller can be configured to receive thetransmitted image data of the first and second scenes from the first andsecond scope devices and the transmitted signal from a tracking device,to determine, based on the transmitted signal, a relative distancebetween the first scope device and the second scope device, and toprovide, based on the transmitted image data and relative distancebetween the first and second scopes, a merged image of at least aportion of at least the first scope device and the second scope devicein a single scene, wherein at least one of the first scope device andthe second scope device in the merged image is a representativedepiction thereof.

An exemplary surgical system can include a variety of features asdescribed herein and illustrated in the drawings. However, a personskilled in the art will appreciate that the surgical systems can includeonly some of these features and/or it can include a variety of otherfeatures known in the art. The surgical systems described herein aremerely intended to represent certain exemplary embodiments. Moreover,while the surgical systems are shown and described in connection withstomach, a person skilled in the art will appreciate that these surgicalsystems can be used in connection with any other suitable natural bodylumens or organs.

Surgery is the most common treatment for stomach cancer. When surgery isrequired for stomach cancer, the goal is to remove the entire tumor aswell as a good margin of healthy stomach tissue around the tumor.Different procedures can be used to remove stomach cancer. The type ofprocedure used depends on what part of the stomach the cancer is locatedand how far it has grown into nearby areas. For example, endoscopicmucosal resection (EMR) and endoscopic submucosal dissection (ESD) areprocedures on the stomach that can be used to treat some early-stagecancers. These procedures do not require a cut in the skin, but insteadthe surgeon passes an endoscope down the throat and into the stomach ofthe patient. Surgical tools (e.g., MEGADYNE™ Tissue Dissector orElectrosurgical Pencils) are then passed through the working channel ofthe endoscope to remove the tumor and some layers of the normal stomachwall below and around it.

Other surgical procedures include a subtotal (partial) or a totalgastrectomy that can be performed as an open procedure (e.g., surgicalinstruments are inserted through a large incision in the skin of theabdomen) or as a laparoscopic procedure (surgical instruments areinserted into the abdomen through several small cuts). A laparoscopicgastrectomy procedure generally involves insufflation of the abdominalcavity with carbon dioxide gas to a pressure of around 15 millimeters ofmercury (mm Hg). The abdominal wall is pierced and a 5-10 mm in diameterstraight tubular cannula or trocar is then inserted into the abdominalcavity. A laparoscope connected to an operating room monitor is used tovisualize the operative field and is placed through one of thetrocar(s). Laparoscopic instruments are placed through two or moreadditional trocars for manipulation by the surgeon and surgicalassistant(s) to remove the desired portion(s) of the stomach.

FIG. 34 illustrates a schematic depiction of a stomach 3000. The stomach3000 can include an esophageal sphincter 3001, a greater curvature 3002,a lesser curvature 3003, a pyloric sphincter 3004, a duodenum 3005, anda duodenojejunal flexure 3006. Additionally, the stomach 3000 includesan inner tissue wall 3007 and an outer tissue wall 3008. The esophagealsphincter 3001 connects the stomach to the esophagus 3009, and allows anendoscope to be passed through a patient's mouth, down the esophagus3009, and passed the esophageal sphincter 3001 in order to access theintraluminal space of the stomach 3000. The pyloric sphincter 3004,duodenum 3005, and duodenojejunal flexure 3006 connect the stomach 3000to the small intestines (not shown).

A conventional surgical procedure to remove a tumor from a stomach iscalled a wedge resection, where the portion of the stomach where thetumor is arranged is removed in full. FIG. 35 and FIG. 36 illustrate anexemplary embodiment of a conventional surgical system that isconfigured for endoluminal and laparoscopic access into a stomach 3050to remove a tumor 3056. Similar to the stomach 3000, the stomach 3050includes an esophageal sphincter 3051, a greater curvature 3052, alesser curvature 3053, a pyloric sphincter 3054, a duodenum 3055, aninner tissue wall 3057, and an outer tissue wall 3058. As illustrated,the tumor 3056 is arranged on the inner tissue wall 3057 of the greatercurvature 3052. The tumor 3056 is arranged away from the esophagealsphincter 3051 and esophagus 3059, and on the inner tissue wall 3057 ofthe greater curvature 3052. In order to remove the tumor 3056, anendoscope 3060 is arranged in the intraluminal space, and a laparoscope3062 is arranged in the extraluminal space.

While both the endoscope 3060 and the laparoscope 3062 are providingimage data to a display so that a surgeon can properly position thescopes and operate on the stomach 3050, the images from each scope areseparate, requiring the surgeon to look at two different monitors, or aframe-in-frame arrangement. This is problematic when both the endoscope3060 and the laparoscope 3062 must work cooperatively in order to createthe incision line I to remove the wedge W with the tumor 3056 attached.The surgeon therefore typically relies on their experience or knowledgeof the anatomy to ensure the endoscope 3060 and laparoscope 3062 areworking cooperatively and arranged in the correct location on eitherside of the inner tissue wall 3057 and outer tissue wall 3058.

With conventional surgical systems, a unified visual image of aconnected or joint surgical treatment site cannot be provided. Instead,a user is required either to monitor multiple displays at the same timeand guess as to the orientation and distance between various surgicalinstruments and/or scopes visualized by different scopes involved in thesame procedure or to incorporate an additional visual system into theprocedure in an attempt to track the scopes and instruments. Thesurgical systems provided herein avoid these issues by integratingimaging from both an endoscope and a laparoscope into a single visualdisplay to simplify alignment and deployment of various surgicalinstruments and scopes.

FIG. 37 illustrates an exemplary embodiment of a surgical system 3100that is configured for endoluminal access into and laparoscopic accessof the stomach 3000. As will be described in more detail below, thesurgical system 3100 can transmit data from different scope devices inorder to create a merged image of a single scene at the surgical site,which can include a representative depiction of at least one of thescope devices in the merged image. For purposes of simplicity, certaincomponents of the surgical system 3100 and the stomach 3000 are notillustrated.

As shown, the stomach 3000 includes a tumor 3040 arranged on the greatercurvature 3002. When operating on the stomach 3000, the blood vessels3064 may need to be manipulated (e.g., mobilized) using laparoscopicallyarranged instruments in order to properly access the tumor 3040. In use,as described in more detail below, the surgical system 3100 can providea merged image so that the endoscope and laparoscope can operatecooperatively while neither scope can visually see the other in theirfield of view (e.g., due to the stomach wall positioned therebetween).

The surgical system 3100 includes an endoscope 3102 that is configuredfor endoluminal access through the esophagus 3009 and into the stomach3000. The endoscope 3102 can have a variety of configurations. Forexample, in this illustrated embodiment, the endoscope 3102 includes afirst optical sensor 3106 (e.g., a camera) and lighting element 3108.Alternatively, or in addition, the endoscope 3102 can include a workingchannel (not shown) arranged along the length of the endoscope 3102 topass an instrument endoluminally into the stomach 3000. In someembodiments, the endoscope 3102 can include an outer sleeve (not shown)configured to be inserted through a patient's mouth (not shown) and downthe esophagus 3009. The outer sleeve can include a working channel thatis configured to allow the endoscope 3102 to be inserted through theouter sleeve and access the stomach 3000. In certain embodiments, theendoscope 3102 can include a working channel extending therethrough.This working channel can be configured to receive one or more surgicalinstruments and/or allow fluid to pass therethrough to insufflate alumen or organ (e.g., the stomach).

Further, the surgical system 3100 includes a laparoscope 3104 that isconfigured for laparoscopic access through the abdominal wall (notshown) and into the extraluminal anatomical space adjacent to thestomach 3000. The laparoscope 3104 can have a variety of configurations.For example, in this illustrated embodiment, the laparoscope 3104includes a second optical sensor 3110 (e.g., a camera) and a lightingelement 3112. Alternatively, or in addition, the laparoscope 3104 caninclude a working channel (not shown) arranged along the length of thelaparoscope 3104 to pass an instrument laparoscopically into theextraluminal space. In some embodiments, the laparoscope 3104 can beinserted into the extraluminal anatomical space through a trocar ormulti-port (not shown) positioned within and through a tissue wall. Thetrocar or multi-port can include ports for passing the laparoscope 3104and/or other surgical instruments into the extraluminal anatomical spaceto access the stomach 3000.

As shown in FIG. 37 , the endoscope 3102 includes a first trackingdevice 3109 disposed on or within the endoscope 3102. The first trackingdevice 3109 is configured to transmit (e.g., to controller 3130) asignal that is indicative of a location of the endoscope 3102 relativeto the laparoscope 3004. Additionally, the laparoscope 3104 includes asecond tracking device 3113 disposed on or within the laparoscope 3104.The second tracking device 3113 is configured to transmit (e.g., tocontroller 3130) a signal that is indicative of a location of thelaparoscope 3104 relative to the endoscope 3102. In other embodiments,only one of the endoscope 3102 and the laparoscope 3104 include atracking device.

Alternatively, or in addition, the transmitted signal (or an additionaltransmitted signal) from the first tracking device 3109 can be furtherindicative of an orientation of the endoscope 3102 relative to thelaparoscope 3004. Alternatively, or in addition, the transmitted signal(or an additional transmitted signal) from the second tracking device3113 can be further indicative of an orientation of the laparoscope 3004relative to the first scope device.

In some embodiments, the first and second tracking devices 3109, 3113are configured to use magnetic or radio frequency sensing to detect alocation, an orientation, or both of the endoscope 3102 and laparoscope3104, respectively (e.g., when the endoscope 3102 and laparoscope 3104positioned on opposite sides of the tissue wall of the stomach 3000).Alternatively, the first and second tracking devices 3109, 3113 areconfigured to use common anatomic landmarks to detect a location, anorientation, or both of the endoscope 3102 and laparoscope 3104,respectively (e.g., when the endoscope 3102 and laparoscope 3104positioned on opposite sides of the tissue wall of the stomach 3000).The first and second tracking devices 3109, 3113 can each transmit thesignal(s) to a controller (like controller 3130). Various embodiments ofmagnetic fiducial markers and using magnetic fiducial markers indetecting location are discussed further, for example, in U.S. Pat. AppNo. 63/249,658 entitled “Surgical Devices, Systems, And Methods ForControl Of One Visualization With Another” filed on Sep. 29, 2021.

As further shown in FIG. 37 and FIG. 38 , the surgical system 3100includes first and second surgical instruments 3114, 3118 that are eachconfigured for laparoscopic access through the abdominal wall and intothe extraluminal anatomical space surrounding the stomach 3000. Thefirst and second surgical instruments 3114, 3118 can have a variety ofconfigurations. For example, in this illustrated embodiment, the firstand second surgical instruments 3114, 3118 each include a pair of jaws3116, 3120, respectively, that are configured to manipulate the stomach3000 from the laparoscopic side. While two surgical instruments 3114,3118 are illustrated, in other embodiments, the surgical system 3100 caninclude one surgical instrument or more than two surgical instruments.In some embodiments, the first and second surgical instruments 3114,3118 can be passed through ports of the same trocar and/or multi-portdevice that the laparoscope 3104 is positioned therethrough.

The surgical system 3100 also includes a controller 3130 communicativelycoupled to the endoscope 3102 and the laparoscope 3104, and isconfigured to receive the transmitted image data of the first and secondscenes from the first and second optical sensors 3106, 3110,respectively. The controller 3130 is also communicatively coupled tofirst and second tracking devices 3109, 3113 and is configured toreceive the transmitted signals from the first and second trackingdevices 3109, 3113, respectively. Once received, the controller 3130 isconfigured to determine at least the relative distance between theendoscope 3102 and the laparoscope 3104. In certain embodiments, thecontroller 3130 can also be configured to determine the relativeorientation between endoscope 3102 and the laparoscope 3104.

As shown in FIG. 38 , the relative distance between the endoscope 3102and the laparoscope 3104 is illustrated in as dashed arrow 3122. Basedon both the transmitted image data and the relative distance betweenendoscope 3102 and the laparoscope 3104, the controller 3130 isconfigured to provide a merged image to a display, for example, on afirst display 3132, a second display 3134, or both of the surgicalsystem 3100. In the merged image, at least one of the endoscope 3102 andthe laparoscope 3104 is a representative depiction thereof.

The first and second displays 3132, 3134 can be configured in a varietyof configurations. For example, in some embodiments, the first displaycan be configured to display the first scene and the second display canbe configured to display the second scene, and the first display, thesecond display, or both, can be further configured to display the mergedimage. In another embodiment, the surgical system 3100 can include, athird display 3136 (FIG. 37 ) that can be used to display the mergedimage, and the first and second displays 3132, 3134 are used to onlyshow the transmitted image data from the optical sensors 3106, 3110,respectively, without any modification. In this embodiment, a surgeoncan access the real-time scenes from both the endoscope 3102 and thelaparoscope 3104 on the first and second displays 3132, 3134, while alsohaving access to the merged image on the third display 3136.

As stated above, the endoscope 3102 includes the first optical sensor3106. The first optical sensor 3106 is configured to transmit image dataof a first scene within a field of view of the endoscope 3102 to thecontroller 3130. In this illustrated embodiment, the tumor 3040 isarranged within the field of view of the endoscope 3102. As a result,the controller 3130, based on the transmitted image data can determinethe relative distance between the endoscope 3102 and the tumor 3040. Asshown in FIG. 38 , the relative distance between the endoscope 3102 andthe tumor 3040 is illustrated as dashed arrow 3127. In some embodiments,the relative distance 3127 can be determined by using structured lightprojected onto the tumor 3040 (e.g., via lighting element 3108) andtracked by the first optical sensor 3106. Further, in some embodiments,the controller 3130 based on the determined relative distances 3122(between the endoscope 3102 and laparoscope 3104) and determinedrelative distance 3127 (between the endoscope 3102 and the tumor 3040),the controller can calculate the relative distance between thelaparoscope 3104 and the tumor 3040.

Additionally, the laparoscope 3104 includes the second optical sensor3110. The second optical sensor 3110 is configured to transmit imagedata of a second scene within a field of view of the laparoscope 3104 tothe controller 3130. The first and second surgical instruments 3114,3118 are arranged within the field of view of the laparoscope 3104. As aresult, the controller 3130, based on the transmitted image data, candetermine the relative distance between the laparoscope 3104 and each ofthe first and second surgical instruments 3114, 3118. In certainembodiments, the controller 3130 can also be configured to determine therelative orientation between the laparoscope 3104 and each of the firstand second surgical instruments 3114, 3118.

As shown in FIG. 38 , the relative distance between the laparoscope 3104and the first surgical instrument 3114 is illustrated as dashed arrow3125, and the relative distance between the laparoscope 3104 and thesecond surgical instrument 3118 is illustrated as dashed arrow 3126. Insome embodiments, the relative distances 3125, 3126 can be determined byusing structured light projected onto the surgical instruments 3114,3118 (e.g., by lighting element 3112) and tracked by the second opticalsensor 3110.

Based on the relative distance 3122 (between the endoscope 3102 andlaparoscope 3104), the relative distance 3125 (between the laparoscope3104 and the first surgical instrument 3114), 3126 (between thelaparoscope 3104 and the second surgical instrument 3118), 3127 (betweenthe endoscope 3102 and the tumor 3040), the controller 3130 candetermine, for example, the relative distance between the endoscope 3102and each of the first surgical instrument 3114 and the second surgicalinstrument 3118, the relative distance between the tumor 3040 and eachof the first instrument 3114 and the second instrument 3118, etc. Asshown in FIG. 38 , the relative distance from the endoscope 3102 to thefirst surgical instrument 3114 is illustrated as dashed arrow 3123, therelative distance from the endoscope 3102 to the second surgicalinstrument 3118 is illustrated as dashed arrow 3124, and the relativedistance from the tumor 3040 to the surgical second instrument 3118 isillustrated as dashed arrow 3128. Based on the determined relativedistances 3123, 3124, 3128, and the transmitted image data (e.g., of thefirst scene, the second scene, or both), the controller can create amerged image that is projected onto the first display 3132, the seconddisplay 3134, or both. Since there is direct imaging of each of theinstruments sets from their respective cameras, and because the systemis able to determine the exact type of devices in use (e.g., graspers,cutters) since the instruments have been scanned into or identified insome form to the surgical hub to allow setup of the system forinteraction with the devices, the system can create a 3D modelrecreation of each of the instruments. With the relative distancesmeasured or at least one coupled 3D axis registration, the system coulddisplay the devices from the occluded camera and invert them in thenecessary manner to show their location, orientation and status inreal-time. These 3D models could even be modified with details directlyimaged from the camera viewing the occluded cooperative image.

Further, in certain embodiments, the controller can also determinerelative orientations between the endoscope 3102 and the laparoscope3104, the first instrument 3114 and/or the second instrument 3118relative to the endoscope 3102 and/or relative to the tumor 3040, etc.Based on the determined relative orientations and the transmitted imagedata (e.g., of the first scene, the second scene, or both), the mergedimage can also illustrate not only the locations, but also theorientations of one or more of the endoscope 3102, the laparoscope 3104,the first surgical instrument 3114, the second surgical instrument 3118,and the tumor 3040. As discussed above, the means to create a completelygenerated 3D model of the instrument that can be overlaid into the imageof the system which cannot see the alternative view. Since therepresentative depiction is a generated image, various properties of theimage (e.g., the transparency, color) can also be manipulated to allowthe system to be clearly shown as not within the real-time visualizationvideo feed, but as a construct from the other view. If the user where toswitch between imaging systems, the opposite view could also have theconstructed instruments within its field of view. In some embodiments,there is another way to generate these overlays. The obstructed imagecould isolate the instruments in its stream from the surroundinganatomy, invert and align the image to the known common axis point andthen merely overlay a live image of the obstructed view into thenon-obstructed view camera display feed. Like the other representativedepiction above, the alternative overlay could be shaded,semi-transparent, or otherwise modified to insure the user can tell thedirectly imaged view from the overlaid view in order to reduceconfusion. This could be done with key aspects of the anatomy as well(e.g., the tumor that can be seen by one camera but not the other). Thesystem could utilize the common reference between the cameras anddisplay the landmark, point of interest, or key surgical anatomy aspectand even highlight it to allow for better approaches and interactioneven from the occluded approach of the key aspect.

FIG. 39 illustrates an exemplary embodiment of a merged image. Themerged image illustrates a real-time first scene within the field ofview of the endoscope 3102 with an overlaid representative depiction ofa portion of the laparoscopic side of the stomach (e.g., the bloodvessels 3064, the laparoscope 3104, and/or the surgical first and secondinstruments 3114, 3118). A person skilled in the art will understandthat the phrase “representative depiction” as used herein refers to avirtual overlay on an actual depiction from a camera, where the virtualoverlay corresponds to the location and orientation of objects which arearranged within the field of view of a camera, but not visible to thecamera due to an obstacle being arranged between the camera and theobjects, and that the phrase “actual depiction” as used herein refers toan unmodified, real-time image or video stream from a camera. Based onthe transmitted image data of the first scene in combination with thedetermined relative distances 3122, 3123, 3124, the controller 3130 canprovide the merged image from the point of view of the endoscope 3102,where the laparoscope 3104 and the surgical instruments 3114, 3118 areshown as representative depictions which correspond to their location inthe extraluminal space in real-time. In the illustrated embodiment, therepresentative depictions are shown in dashed outlines of thecorresponding blood vessels 3064, laparoscope 3104, and surgicalinstruments 3114, 3118. However, other forms of representativedepictions can be used, such as simple geometric shapes to represent thenon-visual instruments and anatomical structures within the intraluminalspace.

Alternatively, or in addition, the controller 3130 can generate a mergedimage from the perspective of the laparoscope 3104. For example, in FIG.40 , the merged image illustrates a the real-time second scene withinthe field of view of the laparoscope 3104 and an overlaid representativedepiction of a portion of the endoscopic side of the stomach (e.g., thetumor 3040 and/or the endoscope 3102). Based on the transmitted imagedata of the second scene in combination with the determined, thecontroller 3130 can provide the merged image from the point of view ofthe laparoscope 3104, where the endoscope 3102 and the tumor 3040 areshown as representative depictions which correspond to their location inthe intraluminal space in real-time. In the illustrated embodiment, therepresentative depictions are shown in dashed outlines of thecorresponding tumor 3040 and endoscope 3102. However, other forms ofrepresentative depictions can be used, such as simple geometric shapesto represent the non-visual instruments and anatomical structures withinthe intraluminal space.

In some embodiments, monitoring of interior and exterior portions ofinterconnected surgical instruments can be performed in order to beimage both the internal and external interactions of the surgicalinstruments with adjacent surgical instruments. In certain embodiments,the surgical instruments that include an articulation actuation systemoutside of the body. Additionally, the surgical instruments can beconfigured to be coupled to electromechanical arms of a robotic system.A tracking device can be used to ensure that robotic arms of differentinstruments do not contact one another outside of the body even thoughthe internal instruments may not be contacting. This system can be usedto control intended and prevent inadvertent interactions oflaparoscopically arranged instruments by monitoring intracorporeal andextracorporeal aspects of the same instruments.

In other embodiments, the coordination of interior and exterior views ofportions of surgical instruments can be accomplished by two separateimaging systems. This would enable the monitoring of the externalinteractions of multiple surgical instruments while controlling andtracking the internal interactions of those same surgical instruments.The system can minimize unintended external interactions between thesurgical instruments while improving the internal operation envelop ofthe same surgical instruments.

Instrument Control Imaging Systems for Visualization of UpcomingSurgical Procedure Steps

Devices, systems, and methods for multi-source imaging provided hereinallow for cooperative surgical visualization that enable instrumentcoordination of the instruments based on a procedure plan for a specificoperation. In general, the present surgical systems provide images ofboth the intraluminal anatomical space and the extraluminal anatomicalspace, and based on these images, provide a merged image in whichcertain surgical steps that are performed endoscopically can becoordinated with a known surgical site in a subsequent step performedlaparoscopically, or vice versa.

For a surgical procedure, there is a corresponding procedure plan whicha surgeon follows as the surgery progresses. The steps in a procedureplan can be performed in a linear fashion in order to achieve a desiredoutcome, such as removing a tumor from a stomach. Through the procedureplan, several steps are known in advance: (i) the tumor must bepartially resected from the inner tissue wall of the stomach; (ii) thestomach must be flipped in order to access the tumor from thelaparoscopic side in order to maintain the stomach in an uprightorientation to prevent stomach acid from spilling out; and (iii) anincision must be made laparoscopically in order to access the tumor.These pieces of information suggest that two different incisions must bemade on the stomach, one to partially remove the tumor, and one tocreate an opening in the stomach wall to access the tumor. Based on thisknowledge that two separate incisions must be made in relatively thesame location, an algorithm can calculate where the first and secondincisions should be located to align the second incision with the firstincision so that the incisions are as small as possible and efficientlymade.

In one exemplary embodiment, the surgical systems can include an energyapplying surgical instrument configured to apply energy to a naturalbody lumen or organ, a first scope device configured to transmit imagedata of a first scene within its field of view, a second scope deviceconfigured to transmit image data of a second scene within its field ofview, and a controller configured to receive the transmitted image dataof the first and second scenes and to provide a merged image of thefirst and second scenes. As a result, the merged image provides twoseparate points of view of the surgical site which allows a medicalpractitioner to coordinate a location of energy to be applied to aninner surface of a tissue wall at the surgical site relative to anintended interaction location of a second instrument on an outer surfaceof the tissue wall in a subsequent procedure step at the surgical site.

The controller is configured to generate a merged image of the first andsecond scenes. The controller receives the actual depiction from each ofthe first imaging system and second imaging system. The actual depictioncan be a photo or a live video feed of what each of the imaging systems,which are attached to each of the scope devices, are seeing in realtime. Each of the first and second scenes depict certain criticalstructures which are not visible by the other imaging system. Forexample, the first imaging system, arranged endoscopically can have atumor and an energy applying surgical instrument within its field ofview. Additionally, the second imaging system can include laparoscopicinstruments arranged within its field of view. Further, as will bediscussed in more detail, the merged image facilitates coordination of alocation of energy to be applied by the energy applying surgicalinstrument to an inner surface of a tissue wall at a surgical siterelative to an intended interaction location of a second instrument onan outer surface of the tissue wall in a subsequent procedure step atthe surgical site.

In some embodiments, the system would need to couple “known” points.These known points would likely be either fixed aspects (e.g.,instrument or scope features, since they are on rigid and predictablesystems) or linked anatomic landmarks (e.g., a known anatomic sphincter,ligament, artery that can be seen from both systems directly). The tumoris likely visible or partially visible in one of imaging systems. Inhollow organ surgeries, the tissue walls are usually thin and the tumorssuperficial to at least one side of the organ. An example would be lungcancer. In lung cancer the tumor would be present in either thedissected parenchyma (i.e. from the lap side) or in the bronchial wall(i.e. from the endoscopic approach). Then the system would only need toidentify one scope with respect to the other in 3D space or identify ananatomic landmark that both scope can see from different points of viewin order to overly the tumor from the side that can see it to theimaging system that cannot.

The first scope device is configured to be at least partially disposedwithin at least one of a natural body lumen and an organ (e.g., a lung,a stomach, a colon, or small intestines), and the second scope device isconfigured to be at least partially disposed outside of the at least oneof the natural body lumen and the organ. In certain embodiments, thefirst scope device is endoscope and the second scope device is alaparoscope. The natural body lumen or organ can be any suitable naturalbody lumen or organ. Non-limiting examples include a stomach, a lung, acolon, or small intestines.

An exemplary surgical system can include a variety of features asdescribed herein and illustrated in the drawings. However, a personskilled in the art will appreciate that the surgical systems can includeonly some of these features and/or it can include a variety of otherfeatures known in the art. The surgical systems described herein aremerely intended to represent certain exemplary embodiments. Moreover,while the surgical systems are shown and described in connection with astomach, a person skilled in the art will appreciate that these surgicalsystems can be used in connection with any other suitable natural bodylumens or organs.

FIG. 41 and FIG. 42 illustrate an exemplary embodiment of a surgicalsystem 3100 that is configured for endoluminal access into andlaparoscopic access of the stomach 3000. Aside from the differencesdescribed in detail below, the surgical system 3200 can be similar tosurgical system 3100 (FIG. 37 and FIG. 38 ) and therefore commonfeatures are not described in detail herein. For purposes of simplicity,certain components of the surgical system 3200 and the stomach 3000 arenot illustrated.

As shown, the stomach 3000 includes an esophageal sphincter 3001, agreater curvature 3002, a lesser curvature 3003, a pyloric sphincter3004, a duodenum 3005, and a duodenojejunal flexure 3006. Additionally,the stomach includes an inner tissue wall 3007, and an outer tissue wall3008. As illustrated, the stomach 3000 includes a tumor 3040 arranged onthe greater curvature 3002. When operating on the stomach 3000, theblood vessels 3064 may need to be manipulated (e.g., mobilized) usinglaparoscopically arranged instruments in order to properly access thetumor 3040. In use, as described in more detail below, the surgicalsystem 3200 can provide a merged image so that energy application andincisions in subsequent procedure steps can be coordinated andvisualized.

The surgical system 3200 includes an endoscope 3202 configured forendoluminal access through the esophagus 3009 and into the stomach 3000.The endoscope 3202 can have a variety of configurations. For example, inthis illustrated embodiment, the endoscope 3202 includes an opticalsensor 3206 (e.g., a camera) and light element 3208. Further, theendoscope 3202 includes a working channel 3203 that is arranged alongthe length of the endoscope 3202. The working channel 3203 is configuredto receive one or more surgical instruments and/or allow fluid to passtherethrough to insufflate a lumen or organ (e.g., the stomach). In someembodiments, the endoscope 3202 can include an outer sleeve (not shown)configured to be inserted through a patient's mouth (not shown) and downthe esophagus 3009. The outer sleeve can include a working channel thatis configured to allow the endoscope 3202 to be inserted through theouter sleeve and access the stomach 3000.

The surgical system 3200 also includes a laparoscope 3204 configured forlaparoscopic access through the abdominal wall (not shown) and into theextraluminal anatomical space adjacent to the stomach 3000. Thelaparoscope 3204 can have a variety of configurations. For example, inthis illustrated embodiment, the laparoscope 3204 includes an opticalsensor 3210 (e.g., a camera) and lighting element 3212. Alternatively,or in addition, the laparoscope 3204 can include a working channel (notshown) arranged along the length of the laparoscope 3204 to pass aninstrument laparoscopically into the extraluminal anatomical space. Insome embodiments, the laparoscope 3204 can be inserted into theextraluminal anatomical space through a trocar or multi-port (not shown)positioned within and through a tissue wall. The trocar or multi-portcan include ports for passing the laparoscope 3204 and/or other surgicalinstruments into the extraluminal anatomical space to access the stomach3000.

As shown in FIG. 41 and FIG. 42 , the surgical system 3200 includes anenergy applying surgical instrument 3240 that passes through the workingchannel 3203 of the endoscope 3202 and into the stomach 3000. While theenergy applying surgical instrument can have a variety ofconfigurations, in this illustrated embodiment, the energy applyingsurgical instrument 3240 includes a blade 3242 at a distal end thereof.The blade 3242 can have a variety of configurations. For example, insome embodiments, the blade can be in the form of mono-polar RF blade oran ultrasonic blade. Exemplary embodiments of energy applying surgicalinstruments that can be used with the present systems are furtherdescribed in U.S. Pat. No. 10,856,928, which is incorporated herein byreference in its entirety. A GEM blade is a Megadyne smart monopolarblade. It is an advanced monopolar blade capable of sensing the tissueand apply the appropriate RF energy need for the task, just likeadvanced bipolar or the smart ultrasonic controls. A person skilled inthe art will appreciate that the type of surgical instrument and thestructural configuration of the surgical instrument, including the endeffector, depends at least upon the surgical site and the surgicalprocedure to be performed.

As further shown in FIG. 41 , the energy applying surgical instrument3202 includes a force sensor 3209 (e.g., the force sensor 3209 can becoupled to one or more motors (not shown) of the instrument 3202 or of arobotic arm (not shown) that is coupled to the instrument 3202). Duringuse, the force sensor 3209 is configured to sense the amount of forcebeing applied by the blade 3242 to the tissue of the stomach 3000 as theblade 3242 moves (e.g., cuts) through the tissue. The force sensor 3209is further configured to transmit the force data to a controller 3230 ofthe surgical system 3200. The controller 3230 can aggregate the receivedfeedback input(s) (e.g., force data), perform any necessarycalculations, and provide output data to effect any adjustments that mayneed to be made (e.g., adjust power level, advancement velocity, etc.).Additional details on the force sensor 3209 and controller 3230 arefurther described in previously mentioned U.S. Pat. No. 10,856,928,which is incorporated herein by reference in its entirety. In someembodiments, the force sensor 3209 can be omitted.

Alternatively, or in addition, the controller 3230 is configured tocalculate an insertion depth of the blade 3242 of the energy applyingsurgical instrument 3240 within tissue of the stomach 30 based on thetransmitted image data from either the endoscope 3202 and/or thelaparoscope 3204. For example, during endoscopic dissection of thestomach wall, the optical sensor 3206 of the laparoscope 3204 canmonitor the dissection site from outside the stomach. Based on thisimage data that is transmitted to the controller 3230, the controller3230 can determine the depth of the blade 3242. This can preventinadvertent full thickness penetration which can result in a leak.Further, the laparoscope 3204 can also monitor heat (via IR wavelength)and collateral thermal damage (tissue refractivity & composition) of thestomach at the dissection site where the energy applying surgicalinstrument is active. This laparoscopic thermal and welding monitoringcan be used to further prevent unnecessary damage to the stomach tissue(e.g., help trigger power adjustments to the energy applying surgicalinstrument). Various embodiments of thermal and welding monitoring insurgical systems to prevent unnecessary damage to tissue are discussedfurther, for example, in U.S. Pat. App No. 63/249,658 entitled “SurgicalDevices, Systems, And Methods For Control Of One Visualization WithAnother” filed on Sep. 29, 2021.

The surgical system 3200 includes first and second surgical instruments3214, 3218 that are each configured for laparoscopic access through theabdominal wall and into the extraluminal anatomical space surroundingthe stomach 3000. The first and second surgical instruments 3114, 3118can have a variety of configurations. For example, in this illustratedembodiment, the first and second surgical instruments 3114, 3118 eachinclude a pair of jaws 3116, 3120, respectively, that are configured tomanipulate the stomach 3000 from the laparoscopic side. While twosurgical instruments 3114, 3118 are illustrated, in other embodiments,the surgical system 3100 can include one surgical instrument or morethan two surgical instruments. In some embodiments, the first and secondsurgical instruments 3114, 3118 can be passed through ports of the sametrocar and/or multi-port device that the laparoscope 3104 is positionedtherethrough.

As stated above, the endoscope 3202 includes the first optical sensor3206. The first optical sensor 3106 is configured to transmit image dataof a first scene within a field of view of the endoscope 3102 to thecontroller 3130. In this illustrated embodiment, the tumor 3040 isarranged within the field of view of the endoscope 3102. As shown inFIG. 41 , the energy applying surgical instrument 3240 is inserted intothe working channel of the endoscope 3202 and the blade 3242 is advancedtowards the tumor 3040. In conventional surgical systems, a surgeonwould partially remove the tumor 3040 using the blade 3242 based on theendoscopic scene only, and then proceed to perform a partial stomachflip blindly (e.g., using only the laparoscopic scene) to remove thetumor 3040 laparoscopically through an incision in the stomach wall. Thesurgeon is not able to coordinate the endoscopic and laparoscopicincisions accurately, and instead approximates where the tumor is duringthe stomach flip, which could lead to inaccurate incisions which removemore tissue than required. However, in the present system 3200, sinceboth the endoscope 3202 and laparoscope 3204 can provide image data ofthe surgical site from both the intraluminal anatomical space and theextraluminal anatomical space, the dissection margin (e.g., where theenergy applying surgical instrument 3240 is going to apply energy topartially remove the tumor) can be coordinated with a second incision(e.g., where a laparoscopic cut will be made in a subsequent procedurestep to remove or detach the tumor 3240 from the stomach.)

The surgical system 3200 also includes a controller 3230 communicativelycoupled to the endoscope 3202 and the laparoscope 3204. The controller3230 is configured to receive the transmitted image data of the firstand second scenes from the first and second optical sensors 3206, 3210and provide a merged image of first and second scenes. This merged imagefacilitates coordination of a location of energy to be applied by theenergy applying surgical instrument 3240 to the inner tissue wall 3057of the stomach at the surgical site 3245 relative to an intendedinteraction location of a second instrument (e.g., cutting instrument3248 having end effectors 3250 in FIG. 43 ) on the outer tissue wall3058 of the stomach in a subsequent procedure step at the surgical site3245.

The controller 3230 is configured to provide a merged image to adisplay, for example, on a first display 3232, a second display 3234, orboth of the surgical system 3200. The first and second displays 3232,3234 can be configured in a variety of configurations. For example, insome embodiments, the first display can be configured to display thefirst scene and the second display can be configured to display thesecond scene, and the first display, the second display, or both, can befurther configured to display the merged image. In another embodiment,the surgical system 3200 can include, a third display that can be usedto display the merged image, and the first and second displays 3232,3234 are used to only show the transmitted image data from the first andsecond optical sensors 3206, 3210, respectively, without anymodification. In this embodiment, a surgeon can access the real-timescenes from both the endoscope 3202 and the laparoscope 3204 on thefirst and second displays 3232, 3234, while also having access to themerged image on the third display 3236.

As illustrated in FIG. 41 a , the display 3232 depicts the scene fromthe endoscope 3202, where the optical sensor 3206 has the tumor 3040,energy applying surgical instrument 3240, and the blade 3242 in itsfield of view. Based on subsequent steps of the procedure plan, thecontroller 3230 can provide a merged image, where a first interactionlocation 3244, including a start location 3244 a and an end location3244 b, is depicted in relation to the tumor 3040 as a representation ofthe intended interaction locations of the energy applying surgicalinstrument 3240. The start location 3244 a corresponds to a start pointof an incision to partially remove the tumor 3040 from the internaltissue wall 3007 of the stomach 3000, and the end location 3244 bcorresponds to an end point of the incision initiated at the startlocation 3244 a. As such, a surgeon would be able to visualize where anincision should start and end, based on subsequent procedure steps. Insome embodiments, one or more of the subsequent steps are based on theprocedure plan. In certain embodiments, one or more of the subsequentprocedure steps can be an adjusted based on the actual surgical stepsrelative to the procedure plan that have already been performed (e.g.,GPS map destination directions recalculated based on user actions duringthe surgical procedure). In some embodiments, the blood vessels 3064 andsurgical instruments 3216, 3220 can be shown in the merged image asrepresentative depictions, similar to the merged images of FIG. 39 .

As illustrated in FIG. 42 , after energy applying surgical instrument isused to partially remove the tumor 3040 from the inner tissue wall 3007of the stomach by applying the blade 3242 to the tissue surrounding thetumor 3040. As illustrated in FIG. 42 a , the blade 3242 traverses fromthe first interaction location 3244 a to the second interaction location3244 b. Once the blade 3242 has reached the second interaction location3244 b, the energy application is terminated as to not fully remove thetumor 3040 from the inner tissue wall 3007.

As stated above, the surgical system 3200 also includes a controller3230 communicatively coupled to the endoscope 3202 and the laparoscope3204, and is configured to receive the transmitted image data of thefirst and second scenes from the first and second optical sensors 3206,3210, respectively. The controller 3230 is also communicatively coupledto first and second tracking devices 3252, 3254 arranged within theendoscope and laparoscope, similar to tracking device 3109, 3113, and isconfigured to receive the transmitted signals from the first and secondtracking devices, respectively. Once received, the controller 3230 isconfigured to determine at least the relative distance between theendoscope 3202 and the laparoscope 3204. In certain embodiments, thecontroller 3230 can also be configured to determine the relativeorientation between endoscope 3202 and the laparoscope 3204.

In some embodiments, the first and second tracking devices 3252, 3254are configured to use magnetic or radio frequency sensing to detect alocation, an orientation, or both of the endoscope 3202 and laparoscope3204, respectively (e.g., when the endoscope 3202 and laparoscope 3204positioned on opposite sides of the tissue wall of the stomach 3000).Alternatively, the first and second tracking devices 3252, 3254 areconfigured to use common anatomic landmarks to detect a location, anorientation, or both of the endoscope 3202 and laparoscope 3204,respectively (e.g., when the endoscope 3202 and laparoscope 3204positioned on opposite sides of the tissue wall of the stomach 3000).The first and second tracking devices 3252, 3254 can each transmit thesignal(s) to a controller (like controller 3230). Various embodiments ofmagnetic fiducial markers and using magnetic fiducial markers indetecting location are discussed further, for example, in U.S. Pat. AppNo. 63/249,658 entitled “Surgical Devices, Systems, And Methods ForControl Of One Visualization With Another” filed on Sep. 29, 2021.

As shown in FIG. 43 , the relative distance between the endoscope 3202and the laparoscope 3204 is illustrated in as dashed arrow 3222. Basedon both the transmitted image data and the relative distance betweenendoscope 3202 and the laparoscope 3204, the controller 3230 isconfigured to provide a merged image to a display, for example, on afirst display 3232, a second display 3234, or both of the surgicalsystem 3200. In the merged image, at least one of the endoscope 3202 andthe laparoscope 3204 is a representative depiction thereof.

As stated above, the endoscope 3202 includes the first optical sensor3206. The first optical sensor 3206 is configured to transmit image dataof a first scene within a field of view of the endoscope 3202 to thecontroller 3230. In this illustrated embodiment, the tumor 3040 isarranged within the field of view of the endoscope 3202. As a result,the controller 3230, based on the transmitted image data can determinethe relative distance between the endoscope 3202 and the tumor 3040. Asshown in FIG. 43 , the relative distance between the endoscope 3202 andthe tumor 3040 is illustrated as dashed arrow 3227. In some embodiments,the relative distance 3227 can be determined by using structured lightprojected onto the tumor 3040 (e.g., via lighting element 3208) andtracked by the first optical sensor 3206. Further, in some embodiments,the controller 3230, based on the determined relative distances 3222(between the endoscope 3202 and laparoscope 3204) and determinedrelative distance 3227 (between the endoscope 3202 and the tumor 3040),the controller can calculate the relative distance between thelaparoscope 3204 and the tumor 3040.

Additionally, the laparoscope 3204 includes the second optical sensor3210. The second optical sensor 3210 is configured to transmit imagedata of a second scene within a field of view of the laparoscope 3204 tothe controller 3230. The cutting instrument 3248 is arranged within thefield of view of the laparoscope 3204. As a result, the controller 3230,based on the transmitted image data, can determine the relative distancebetween the laparoscope 3204 and the cutting instrument 3248. In certainembodiments, the controller 3230 can also be configured to determine therelative orientation between the laparoscope 3204 and the cuttinginstrument 3248.

As shown in FIG. 43 , the relative distance between the laparoscope 3204and the cutting instrument 3248 is illustrated as dashed arrow 3225. Insome embodiments, the relative distances 3225 can be determined by usingstructured light projected onto the cutting instrument 3248 (e.g., bylighting element 3212) and tracked by the second optical sensor 3210.

Based on the relative distance 3222 (between the endoscope 3202 andlaparoscope 3204), the relative distance 3225 (between the laparoscope3204 and the cutting instrument 3248), and the relative distance 3227(between the endoscope 3202 and the tumor 3040), the controller 3230 candetermine, for example, the relative distance between the tumor 3040 andcutting instrument 3248 and the cutting plane of the cutting instrument3248. As shown in FIG. 43 , the relative distance from the tumor 3040 tothe cutting instrument 3248 is illustrated as dashed arrow 3223. Basedon the determined relative distances 3223, and the transmitted imagedata (e.g., of the first scene, the second scene, or both), thecontroller can create a merged image that is projected onto the firstdisplay 3232, the second display 3234, or both. Since there is directimaging of each of the instruments sets from their respective cameras,and because the system is able to determine the exact type of devices inuse (e.g., graspers, cutters) since the instruments have been scannedinto or identified in some form to the surgical hub to allow setup ofthe system for interaction with the devices, the system can create a 3Dmodel recreation of each of the instruments. With the relative distancesmeasured or at least one coupled 3D axis registration, the system coulddisplay the devices from the occluded camera and invert them in thenecessary manner to show their location, orientation and status inreal-time. These 3D models could even be modified with details directlyimaged from the camera viewing the occluded cooperative image.

As illustrated in FIG. 43 a , the location of the first interactionlocation 3244 is coordinated with the location of a second interactionlocation 3246 so that the first interaction location 3244 abuts thesecond interaction location 3246. The controller 3230 can provide amerged image shown on the display 3234, where a second interactionlocation 3246 is depicted in relation to the tumor 3040 and the firstinteraction location 3244 as a representation of the intendedinteraction location of the surgical instrument 3218. In thisillustrated embodiment, the second interaction location 3246 correspondsto an incision to open the stomach 3000 after a portion of the stomachhas been flip procedure in order to remove the tumor 3040 from thestomach 30 laparoscopically.

Due to this coordination and alignment of the first interaction location3244 and the second interaction location 3246, there is minimal damageto the surrounding tissue of the stomach 3000 when incisions are createdusing the interaction locations 3244, 3246 as guides. The secondinteraction location 3246 is able to be placed at the exact location ofthe tumor 3040, even though the tumor is not visible from thelaparoscopic side. Due to the endoscope 3202 being able to visualize thetumor, and communicate with the controller 3230. In the illustratedembodiment, the interaction locations 3244, 3246 are shown in dashedoutlines. However, other forms of representative depictions, such assimple geometric shapes, can be used.

In some embodiments, coordination of lesion removal can be effected withexternally supported orientation control via laparoscopic instruments orretractors. Alternatively, or in addition, coordination of lesionremoval can be effected with internally supported balloon orientationcontrol closure. For example, a surgical systems 3150 that is configuredfor lesion removal using an endoscopic and laparoscopic approach, incombination with an endoscopically supported balloon is illustrated inFIG. 44 a , can be provided. This is an alternate procedure that hasboth intra luminal and extra luminal interactive operations. Thesubmucosal dissection and separation is done within the colon. Thedissection is stopped before full perimeter dissection is done. Anincision is then made in the colon wall and the tumor flipped out intothe extra luminal space. The endocutter is the brought into bothseal/transect the tumor from the remaining attachment and to close theincision defect. This is done to minimize invasiveness and trauma andseal and remove the tumor since it is not really able to be doneentirely intraluminal. This requires the same cooperation andinteraction from devices and landmarks on both side of an organ wallthat is only viewable from one side at a time.

The surgical system 3150 includes a surgical instrument 3152 having acutting tip 3154. The cutting tip 3154 is arranged at the distal end ofthe surgical instrument 3152. As illustrated in FIG. 44 a , an initialmucosal incision 3158 can be made in the colon 3151 from the endoscopicside by the surgical instrument 3152. The mucosal incision 3158 is madearound the lesion 3156 in order to prepare the lesion 3156 for removal,with the mucosal incision 3158 being only partially around the lesion3156. As illustrated in FIG. 44 b , an incision 3160 can be made in theseromuscular layer of the colon 3151 completely around the lesion 3156after the mucosal incision 3158 is made. As illustrated in FIG. 44 c ,balloons 3162, 3164 are endoscopically arranged on either side of thearea of the colon 3151 where the lesion 3156 is located. Even though notshown in the FIG. 44 a and FIG. 44 b , the balloons 3162, 3164 arepresent and inflated during the creation of the mucosal incision 3158and the seromuscular incision 3160. The balloons 3162, 3164 providetension to the colon 3151 to allow for a cleaner incision, and alsoreduce the likelihood that the lesion 3156 will contact the contents ofthe colon 3151 during removal through the “crown method.” As illustratedin FIG. 44 d , with the mucosal incision 3158 and the seromuscularincision 3160, the lesion 3156 can be removed by laparoscopicallyarranged instruments 3166, 3168. With the lesion 3156 removed, the hole3170 left by the removal can be stapled closed by staples 3172, asillustrated in FIG. 44 e.

Coordinated Instrument Control Systems

Surgical systems that allow for coordinated imaging, such as thesurgical systems described above, can also include coordination of theinstruments at a specific step of an operation. Since the surgicalsystems can provide images of both the intraluminal space and theextraluminal space, certain surgical steps which require both endoscopicand laparoscopic coordination with a known surgical site can beperformed.

The surgical systems include surgical imaging systems described above,which can be used to track and locate various scopes and instrumentsarranged on opposite sides of a tissue wall, and provide a merged image.Since the merged image shows the orientation and location of instrumentsand scopes arranged on opposite sides of a tissue wall which are notvisible to each scope, the instruments can be arranged on either side ofthe tissue wall in order to coordinate motion of the instruments fromeither side of the tissue wall.

For a surgical procedure, there may be a surgical step which requirescoordination between instruments arranged endoscopically andlaparoscopically. For example, during a procedure to remove a tumor froma stomach, an incision must be made laparoscopically to access thetumor, and then the tumor must be passed from the intraluminal space tothe extraluminal space for removal. However, the endoscopically arrangedinstruments and the laparoscopically instruments used to pass the tumorthrough the incision cannot visually see the each other while thehandoff is occurring. However, in combination with the imaging systemsof the endoscope and laparoscope, the instruments can be coordinated toalign with the incision in the stomach wall to pass the tumor throughthe incision since the instruments can be visualized through the stomachwall.

In one exemplary embodiment, the surgical system can include a firstscope device configured to transmit image data of a first scene.Further, a second scope device is configured to transmit image data of asecond scene, the first scene being different than the second scene. Atracking device is associated with one of the first scope device or thesecond scope device and configured to transmit a signal indicative of alocation of one of the first scope device or the second scope devicerelative to the other one of the first scope device or the second scopedevice. A first surgical instrument is configured to interact with aninternal side of a target tissue structure. A second surgical instrumentis configured to interact an external side of the target tissuestructure. A controller is configured to receive the transmitted imagedata and transmitted signal. Based on the transmitted signal and imagedata, the controller can determine on a first relative distance from thefirst scope device to the second scope device, a second relativedistance from the first scope device to the first surgical instrumentpositioned within at least one natural body lumen and organ, and a thirdrelative distance from the second scope to the second surgicalinstrument positioned outside of at least one natural body lumen and theorgan. Relative movements of the instruments are coordinated based onthe determined relative distances.

The controller is further configured to generate a merged image of thefirst and second scenes. The controller receives the actual depictionfrom each of the first imaging system and second imaging system. Theactual depiction can be a photo or a live video feed of what each of theimaging systems, which are attached to each of the scope devices, areseeing in real time. Each of the first and second scenes depict certaincritical structures that are not visible by the other imaging system.For example, the first imaging system, arranged endoscopically, can havea tumor and a surgical instrument within its field of view.Additionally, the second imaging system can include laparoscopicinstruments arranged within its field of view. Further, as will bediscussed in more detail, the merged image facilitates coordination ofthe relative movements of both endoscopic and laparoscopic instrumentsat a surgical site.

An exemplary surgical system can include a variety of features asdescribed herein and illustrated in the drawings. However, a personskilled in the art will appreciate that the surgical systems can includeonly some of these features and/or it can include a variety of otherfeatures known in the art. The surgical systems described herein aremerely intended to represent certain exemplary embodiments. Moreover,while the surgical systems are shown and described in connection with astomach, a person skilled in the art will appreciate that these surgicalsystems can be used in connection with any other suitable natural bodylumens or organs.

FIG. 45 illustrates an exemplary embodiment of a surgical system 3300that is configured for endoluminal access into and laparoscopic accessof the stomach 3000. Aside from the differences described in detailbelow, the surgical system 3300 can be similar to surgical system 3100(FIG. 37 and FIG. 38 ) and therefore common features are not describedin detail herein. For purposes of simplicity, certain components of thesurgical system 3300 and the stomach 3000 are not illustrated.

As shown, the stomach 3000 includes an esophageal sphincter 3001, agreater curvature 3002, a lesser curvature 3003, a pyloric sphincter3004, a duodenum 3005, and a duodenojejunal flexure 3006. Additionally,the stomach includes an inner tissue wall 3007, and an outer tissue wall3008. As illustrated, the stomach 3000 includes a tumor 3040 arranged onthe greater curvature 3002. When operating on the stomach 3000, theblood vessels 3064 may need to be manipulated (e.g., mobilized), such asby using laparoscopically arranged instruments, to properly access thetumor 3040. In use, as described in more detail below, the surgicalsystem 3200 can provide a merged image so that energy application andincisions in subsequent procedure steps can be coordinated andvisualized.

The surgical system 3300 includes an endoscope 3302 configured forendoluminal access through the esophagus 3009 and into the stomach 3000.The endoscope 3302 can have a variety of configurations. For example, inthis illustrated embodiment, the endoscope 3302 includes an opticalsensor 3306 (e.g., a camera) and light element 3308. Further, theendoscope 3302 includes a working channel 3303 that is arranged alongthe length of the endoscope 3302. The working channel 3303 is configuredto receive one or more surgical instruments and/or allow fluid to passtherethrough to insufflate a lumen or organ (e.g., the stomach). In someembodiments, the endoscope 3302 can include an outer sleeve (not shown)configured to be inserted through a patient's mouth (not shown) and intothe esophagus 3009. The outer sleeve can include a working channel thatis configured to allow the endoscope 3302 to be inserted through theouter sleeve and access the stomach 3000.

The surgical system 3300 also includes a laparoscope 3304 configured forlaparoscopic access through the abdominal wall (not shown) and into theextraluminal anatomical space adjacent to the stomach 3000. Thelaparoscope 3304 can have a variety of configurations. For example, inthis illustrated embodiment, the laparoscope 3304 includes an opticalsensor 3310 (e.g., a camera) and lighting element 3312. Alternatively,or in addition, the laparoscope 3304 can include a working channel (notshown) arranged along the length of the laparoscope 3304 to pass aninstrument laparoscopically into the extraluminal anatomical space. Insome embodiments, the laparoscope 3304 can be inserted into theextraluminal anatomical space through a trocar or multi-port (not shown)positioned within and through a tissue wall. The trocar or multi-portcan include ports for passing the laparoscope 3304 and/or other surgicalinstruments into the extraluminal anatomical space to access the stomach3000.

The endoscope 3302 includes a tracking device 3309 arranged with theendoscope 3302. The tracking device 3309 is configured to transmit asignal indicative of a location of the endoscope 3302 relative to thelaparoscope 3304. Additionally, laparoscope 3304 includes a trackingdevice 3313 associated with the laparoscope 3304. The tracking device3313 is configured to transmit a signal indicative of a location of thelaparoscope 3304 relative to the endoscope 3302. In some embodiments,the tracking devices 3309, 3313 are configured to use magnetic or radiofrequency sensing to detect a location and orientation of the endoscope3302 and laparoscope 3304 arranged opposite sides of the tissue wall ofthe stomach 3000. Alternatively, the tracking devices 3309, 3313 areconfigured to use common anatomic landmarks to detect a location andorientation of the endoscope 3302 and laparoscope 3304 arranged oppositesides of the tissue wall of the stomach 3000. The tracking devices 3309,3313 can determine a relative distance represented by dashed arrow 3341,which is indicative of the location of one of the endoscope 3302 andlaparoscope 3304 relative to the other scope device.

In some embodiments, the first and second tracking devices 3309, 3313are configured to use magnetic or radio frequency sensing to detect alocation, an orientation, or both, of the endoscope 3302 and laparoscope3304, respectively (e.g., when the endoscope 3302 and laparoscope 3304positioned on opposite sides of the tissue wall of the stomach 3000).Alternatively, the first and second tracking devices 3309, 3313 areconfigured to use common anatomic landmarks to detect a location, anorientation, or both, of the endoscope 3302 and laparoscope 3304,respectively (e.g., when the endoscope 3302 and laparoscope 3304positioned on opposite sides of the tissue wall of the stomach 3000).The first and second tracking devices 3309, 3313 can each transmit thesignal(s) to a controller (like controller 3330). Various embodiments ofmagnetic fiducial markers and using magnetic fiducial markers indetecting location are discussed further, for example, in U.S. Pat. AppNo. 63/249,658 entitled “Surgical Devices, Systems, And Methods ForControl Of One Visualization With Another” filed on Sep. 29, 2021.

As shown in FIG. 45 , the surgical system 3300 includes a surgicalinstrument 3360 that passes through the working channel 3303 of theendoscope 3302 and into the stomach 3000. While the surgical instrumentcan have a variety of configurations, in this illustrated embodiment,the surgical instrument 3360 includes graspers 3362 at a distal endthereof. A person skilled in the art will appreciate that the type ofsurgical instrument and the structural configuration of the surgicalinstrument, including the end effector, depends at least upon thesurgical site and the surgical procedure to be performed. While only onesurgical instrument 3360 is illustrated, in other embodiments, thesurgical system 3300 can include more than one surgical instrumentarranged in the working channel of the endoscope.

As further shown in FIG. 45 , the surgical instrument 3360 includes aforce sensor 3319 (e.g., the force sensor 3319 can be coupled to one ormore motors (not shown) of the instrument 3360 or of a robotic arm (notshown) that is coupled to the instrument 3360). During use, the forcesensor 3319 is configured to sense the amount of force being applied bythe graspers 3362 to the tissue of the stomach 3000 as the graspers 3362manipulate the tissue. The force sensor 3319 is further configured totransmit the force data to a controller 3330 of the surgical system3300. The controller 3330 can aggregate the received feedback input(s)(e.g., force data), perform any necessary calculations, and provideoutput data to effect any adjustments that may need to be made (e.g.,adjust power level, advancement velocity, etc.). Additional details onthe force sensor 3319 and controller 3330 are further described inpreviously mentioned U.S. Pat. No. 10,856,928, which is incorporatedherein by reference in its entirety. In some embodiments, the forcesensor 3319 can be omitted.

The surgical system 3300 includes first and second surgical instruments3314, 3318 that are each configured for laparoscopic access through theabdominal wall and into the extraluminal anatomical space surroundingthe stomach 3000. The first and second surgical instruments 3314, 3318can have a variety of configurations. For example, in this illustratedembodiment, the surgical instruments 3314, 3318 include graspers 3316,3320, respectively. While two surgical instruments 3314, 3318 areillustrated, in other embodiments, the surgical system 3300 can includemore than two surgical instruments. The surgical instruments 3314, 3318are configured to be inserted through the abdominal wall and into theextraluminal space to manipulate and/or operate on the stomach 3000 fromthe laparoscopic side. In some embodiments, the first and secondsurgical instruments 3314, 3318 can be passed through ports of the sametrocar and/or multi-port device that the laparoscope 3304 is positionedtherethrough.

The surgical instrument 3314 includes a force sensor 3317 arranged withthe surgical instrument 3314. The force sensor 3317 is configured tosense an applied force to the target tissue structure by the surgicalinstrument 3314. Additionally, the surgical instrument 3318 includes aforce sensor 3321 arranged with the surgical instrument 3318. The forcesensor 3321 is configured to sense an applied force to the target tissuestructure by the surgical instrument 3318. The controller 3330 isfurther configured to determine an amount of strain that is applied tothe stomach 3000 by at least one of the surgical instruments 3314, 3318via the force sensors 3317, 3321.

As stated above, the endoscope 3302 includes the optical sensor 3306.The optical sensor 3306 is configured to transmit image data of a firstscene within a field of view of the endoscope 3302 to the controller3330. As shown in FIG. 45 , the surgical instrument 3340 is insertedinto the working channel of the endoscope 3302 and advanced towards thetumor 3040. In conventional surgical systems, a surgeon would perform apartial stomach flip blindly (e.g., using only the laparoscopic scene)to remove the tumor 3040 laparoscopically through an incision in thestomach wall. The surgeon is not able to coordinate the endoscopic andlaparoscopic instruments accurately, and instead approximates thelocation of the tumor and instruments during the stomach flip,potentially leading to inaccurate removal of the tumor and the removalmore tissue than needed. However, in the present system 3300, since boththe endoscope 3302 and laparoscope 3304 can provide image data of thesurgical site from both the intraluminal anatomical space and theextraluminal anatomical space, the handoff of the tumor through theincision from the intraluminal space to the extraluminal space can becoordinated between both sets of instruments.

As shown in FIG. 45 , the endoscope 3302 can determine the location ofthe tumor 3040 and incision 3340 based on the relative distance 3343,and the location of the surgical instrument 3360, which is sensed by theoptical sensor 3306 and determined by the controller 3330. In someembodiments, the relative distance 3343 is determined using structuredlight projected onto the tumor 3040 and/or surgical instrument 3360 andtracked by the optical sensor 3306. Additionally, the laparoscope 3304includes the optical sensor 3310. The optical sensor 3310 is configuredto transmit image data of a second scene within a field of view of thelaparoscope 3304. The surgical instruments 3314, 3318 are arrangedwithin the field of view of the laparoscope 3304. As shown in FIG. 45 ,the laparoscope 3304 can determine the location of the surgicalinstruments 3318 based on the relative distance 3344, which is measuredby the optical sensor 3310 and determined by the controller 3330. Insome embodiments, the relative distance 3344 is determined by usingstructured light projected onto the surgical instrument 3318 and trackedby the optical sensor 3310.

The surgical system 3300 also includes a controller 3330 communicativelycoupled to the endoscope 3302 and the laparoscope 3304. The controller3330 is configured to receive the transmitted image data of the firstand second scenes from the optical sensors 3306, 3310. The controller3330 is also configured to determine, based on the transmitted signals,a relative distance from the endoscope 3302 to the laparoscope device3304 represented by dashed arrow 3341, a relative distance from thetumor 3040 to the surgical instrument 3318 represented by dashed arrow3342, a relative distance from the endoscope 3302 to the tumor 3040represented by dashed arrow 3343, and a relative distance from thelaparoscope 3304 to the surgical instrument 3318 positioned outside ofat least one natural body lumen and the organ represented by dashedarrow 3344.

As illustrated in FIG. 46 , based on the determined relative distances,a merged image is provided by the controller 3330 to depict the scenewithin the field of view of the laparoscope 3304, while also overlayinga representative depiction of the objects arranged only within view ofthe endoscope 3302 such as the tumor and the surgical instrument 3360.The optical sensor 3310 has the surgical instruments 3314, 3318 and theouter tissue wall 3007 in its field of view, and cannot visually detectthe tumor 3040, endoscope 3302, or the surgical instrument 3360.

The controller 3330 is configured to provide a merged image to adisplay. The displays can be configured in a variety of configurations.For example, in some embodiments, a first display can be configured todisplay the first scene and a second display can be configured todisplay the second scene, and the first display, the second display, orboth, can be further configured to display the merged image. In anotherembodiment, the surgical system 3300 can include, a third display thatcan be used to display the merged image, and the first and seconddisplays are used to only show the transmitted image data from the firstand second optical sensors 3306, 3310, respectively, without anymodification. In this embodiment, a surgeon can access the real-timescenes from both the endoscope 3302 and the laparoscope 3304 on thefirst and second displays while also having access to the merged imageon the third display.

Based on the relative distances 3341, 3342, 3343, 3344 determined by thecontroller 3330, the controller 3330 can provide the merged image fromthe point of view of the laparoscope 3304, where the endoscope 3302 andthe surgical instrument 3360 are shown as representative depictionswhich correspond to their location in the intraluminal space inreal-time. In the illustrated embodiment, the representative depictionsare shown in dashed outlines of the endoscope 3302 and surgicalinstrument 3360. However, other forms of representative depictions canbe used, such as simple geometric shapes to represent the non-visualinstruments and anatomical structures within the intraluminal space. Byusing the merged image, a surgeon can arrange the surgical instrumentsin a proper position in order to operate on the stomach 3000. With themobilized tumor 3040 produced in the merged image, along with theendoscope 3302 and surgical instrument 3360, the surgical instrument3360 can be coordinated through movement commands input by a user toalign the partially removed tumor 3040 with the incision made in thestomach wall. The surgical instrument 3318 can also be coordinatedthrough movement commands input by the user to align the surgicalinstrument 3318 with the incision 3340 on the laparoscopic side. Assuch, when the tumor 3040 is at least partially passed through theincision 3340 by the surgical instrument 3360 from the intraluminalspace to the extraluminal space, the surgical instrument 3318 can graspthe tumor 3040 and aid in removing the tumor 3040 from the stomach 3000.

In use, the controller 3330 can be configured to restrict movement ofthe surgical instrument 3314 and the surgical instrument 3318 relativeto each other at the target tissue structure (e.g., tumor 3040) based onthe transmitted image data of the first and second scenes and therelative distances 3341, 3342, 3342 through the robotic arms which thesurgical instruments are attached to.

As illustrated in FIG. 47 , the controller 3330 is further configured todetermine an amount of strain that is applied to the stomach 3000 by atleast one of the surgical instruments 3314, 3318 with the use of visualmarkers 3350, 3352 associated with the stomach 3000. The visual markers3350, 3352 are at least one of one or more local tissue markings on thestomach 30, one or more projected light markings on the stomach 3000, orone or more anatomical aspects of at least one of the stomach 3000. Thevisual markers 3350, 3352 are detected by the optical sensor 3306 of theendoscope 3302 or the optical sensor 3310 of the laparoscope 3304. Inuse, the optical sensor 3306 or optical sensor 3310 senses the movementof the visual marker 3350 as it transitions to the visual marker 3352.

As illustrated in FIG. 48 , the surgical system 3400 can be used foroptical temperature sensing methods in order to sense the externaltemperature of the stomach 3000 while an ablation is occurringinternally to ensure that certain layers of the stomach 3000 are notdamaged. Aside from the differences described in detail below, thesurgical system 3400 can be similar to surgical system 3300 (FIG. 45 )and therefore common features are not described in detail herein. Thetemperature monitoring methods can be used to restrict the applicationof energy by an energy applying surgical instrument 3440 endoscopically.For example, an energy applying surgical instrument 3440 isendoscopically arranged through the endoscope 3402. Additionally, alaparoscope 3404 and a surgical instrument 3418 are laparoscopicallyarranged in the extraluminal space. The laparoscope 3404 includes anoptical sensor 3410 and a light 3412.

In use, in order to remove lymph nodes 3080, the energy applyingsurgical instrument 3440 can apply an energy to the internal wall 3007of the stomach 3000. The laparoscopically arranged surgical instrument3418 can be arranged to grasp the lymph nodes 3080. As the energyapplying instrument applies energy to the lymph nodes, the opticalsensor 3410 can detect the temperature of the tissue of the stomach3000, and reduce the amount of energy applied if the temperature becomestoo high in order to prevent tissue damage.

In some embodiments, the surgical system 3400 can be used for control ofmid-thickness ablation (e.g., thermal, electrical, or microwave)controlled by one imaging access system by coordinating it with a secondsystem viewing from a different point-of-view, similar to surgicalsystem 3000. Additionally, after removal of a tumor, the final ablationfrom the endoscopic side could be used to expand the margin around thesite of the tumor to insure complete removal of the cancer. For example,where a cancerous tumor is close to the esophageal sphincter,maintenance of the sphincter is important to preventing acid reflux fromoccurring and thus it is useful to maintain as much healthy tissue aspossible avoid unnecessary expansive dissection and resection.

The surgical systems disclosed herein can be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the surgical systems can be reconditioned forreuse after at least one use. Reconditioning can include any combinationof the steps of disassembly of the surgical systems, followed bycleaning or replacement of particular pieces and subsequent reassembly.In particular, the surgical systems can be disassembled, and any numberof the particular pieces or parts of the surgical systems can beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, the surgical systems can be reassembledfor subsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a surgical systems can utilize avariety of techniques for disassembly, cleaning/replacement, andreassembly. Use of such techniques, and the resulting reconditionedinstrument, are all within the scope of the present application.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a user, such as a clinician, gripping a handleof an instrument. It will be appreciated that the terms “proximal” and“distal” are used herein, respectively, with reference to the top end(e.g., the end that is farthest away from the surgical site during use)and the bottom end (e.g., the end that is closest to the surgical siteduring use) of a surgical instrument, respectively. Other spatial termssuch as “front” and “rear” similarly correspond respectively to distaland proximal. It will be further appreciated that for convenience andclarity, spatial terms such as “vertical” and “horizontal” are usedherein with respect to the drawings. However, surgical instruments areused in many orientations and positions, and these spatial terms are notintended to be limiting and absolute.

Values or ranges may be expressed herein as “about” and/or from/of“about” one particular value to another particular value. When suchvalues or ranges are expressed, other embodiments disclosed include thespecific value recited and/or from/of the one particular value toanother particular value. Similarly, when values are expressed asapproximations, by the use of antecedent “about,” it will be understoodthat here are a number of values disclosed therein, and that theparticular value forms another embodiment. It will be further understoodthat there are a number of values disclosed therein, and that each valueis also herein disclosed as “about” that particular value in addition tothe value itself. In embodiments, “about” can be used to mean, forexample, within 10% of the recited value, within 5% of the recited valueor within 2% of the recited value.

For purposes of describing and defining the present teachings, it isnoted that unless indicated otherwise, the term “substantially” isutilized herein to represent the inherent degree of uncertainty that maybe attributed to any quantitative comparison, value, measurement, orother representation. The term “substantially” is also utilized hereinto represent the degree by which a quantitative representation may varyfrom a stated reference without resulting in a change in the basicfunction of the subject matter at issue.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety. Any patent, publication, orinformation, in whole or in part, that is said to be incorporated byreference herein is only to the extent that the incorporated materialdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this document. As such the disclosureas explicitly set forth herein supersedes any conflicting materialincorporated herein by reference.

What is claimed is:
 1. A surgical anchoring system, comprising: asurgical instrument configured for endoluminal access, the surgicalinstrument having: an outer sleeve defining a working channeltherethrough, the outer sleeve configured to be at least partiallydisposed within a first natural body lumen; and at least one channel armconfigured to extend through the working channel, the at least onechannel arm having: at least one anchor member coupled to the at leastone channel arm and configured to move between expanded and unexpandedstates, wherein when in the expanded state, the at least one anchormember is configured to be at least partially disposed within a secondnatural body lumen, the second natural body lumen being in communicationwith the first natural body lumen; and at least one control actuatorextending along the at least one channel arm and operatively coupled tothe at least one anchor member, the at least one control actuator beingoperatively coupled to a drive system that is configured to controlmotion of the at least one channel arm to selectively manipulate anorgan associated with the first and second natural body lumens.
 2. Thesurgical anchoring system of claim 1, wherein the surgical instrumentincludes an anchoring balloon arranged proximal to a distal end of theouter sleeve.
 3. The surgical anchoring system of claim 2, wherein theanchoring balloon is configured to expand and at least partially contactan internal surface of the first natural body lumen.
 4. The surgicalanchoring system of claim 1, wherein the at least one anchor member isconfigured to expand and at least partially contact the internal surfaceof the second natural body lumen.
 5. The surgical anchoring system ofclaim 1, wherein the at least one channel arm is configured to apply aforce to the second natural body lumen through at least one anchormember so as to manipulate the second natural body lumen relative to thefirst natural body lumen.
 6. The surgical anchoring system of claim 1,wherein the at least one channel arm includes an optical sensor arrangedat a distal end of the at least one channel arm.
 7. The surgicalanchoring system of claim 1, further comprising a controller that isconfigured to coordinate a motion of the at least one channel arm withinthe second natural body lumen and a motion of at least one instrumentoutside of the second natural body lumen to prevent tearing of thesecond natural body lumen.
 8. The surgical anchoring system of claim 1,wherein the at least one anchor member is configured to move axiallyalong a length of the channel arm.
 9. The surgical anchoring system ofclaim 8, wherein the at least one anchor member is configured to beselectively locked at an axial position along the length of the at leastone channel arm by a releasable locking mechanism.
 10. A surgicalanchoring system, comprising: a tubular member configured forendoluminal access and having a central lumen therein configured toallow an endoscope to pass therethrough; an anchoring assembly coupledto a distal portion of the tubular member and extending distallytherefrom, the anchoring assembly comprising: a first anchor membercoupled to the tubular member and configured to engage a firstanatomical location and secure the first anatomical location relative tothe tubular member; and a second anchor member moveable relative to thefirst anchor member and positioned distal to the first anchor member andconfigured to engage a second anatomical location that is moveablerelative to the first anatomical location; wherein movement of thesecond anchor member relative to the first anchor member is effective toselectively reposition the second anatomical location relative to thefirst anatomical location.
 11. The surgical anchoring system of claim10, wherein the first anchor member comprises a first plurality ofworking channels extending therethrough and a first plurality ofexpandable anchoring elements.
 12. The surgical anchoring system ofclaim 11, wherein the second anchor member comprises a second pluralityof working channels extending therethrough and a second plurality ofexpandable anchoring elements.
 13. The surgical anchoring system ofclaim 12, wherein the tubular member further comprises a third pluralityof working channels extending therethrough.
 14. The surgical anchoringsystem of claim 13, further comprising a plurality of first actuatorsthat pass through first working channels of the first plurality ofworking channels of the first anchor member and first working channelsof the third plurality of working channels of the tubular member. 15.The surgical anchoring system of claim 14, wherein the plurality offirst actuators are configured to rotate to expand the first pluralityof expandable anchoring elements.
 16. The surgical anchoring system ofclaim 13, further comprising a plurality of second actuators that passthrough second working channels of the first plurality of workingchannels of the first anchor member, first working channels of thesecond plurality of working channels of the second anchor member, andsecond working channels of the third plurality of working channels ofthe tubular member.
 17. The surgical anchoring system of claim 16,wherein the plurality of second actuators are configured to rotate toexpand the second plurality of expandable anchoring elements.
 18. Thesurgical anchoring system of claim 13, further comprising a plurality ofthird actuators that pass through third working channels of the firstplurality of working channels of the first anchor member and thirdworking channels of the third plurality of working channels of thetubular member, and terminate at a proximal surface of the second anchormember.
 19. The surgical anchoring system of claim 18, wherein theplurality of third actuators are configured to rotate to axiallydisplace the second anchor member relative to the first anchor member.20. The surgical anchoring system of claim 18, wherein the plurality ofthird actuators are configured to be extended, retracted, or bent toselectively reposition the second anatomical location relative to thefirst anatomical location.